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- || felcisetrag (TAK-954) / Theravance Biopharma
Clinical, P2 data, Journal, Surgery: A randomized phase 2 study of the 5-HT4 receptor agonist felcisetrag for postoperative gastrointestinal dysfunction after bowel surgery. (Pubmed Central) - Jul 4, 2024
P2
However, no clinically meaningful difference in time to recovery of gastrointestinal function versus placebo was observed. Further investigation of the utility of 5-HT4 agonists in complicated, open abdominal surgeries may be warranted.
- || felcisetrag (TAK-954) / Theravance Biopharma, Resolor (prucalopride) / J&J, Takeda, velusetrag (TD-5108) / Innoviva
Retrospective data, Review, Journal: Safety and Efficacy of Highly Selective 5-Hydroxytryptamine Receptor 4 Agonists for Diabetic and Idiopathic Gastroparesis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (Pubmed Central) - Feb 8, 2024
While the overall adverse effect profile is deemed acceptable, larger studies with extended follow-up periods are needed to investigate rare and/or serious adverse events. Moreover, future high-quality RCTs comparing the efficacy and safety of these novel agents with currently available agents are essential to further validate these findings.
- felcisetrag (TAK-954) / Theravance Biopharma, Resolor (prucalopride) / J&J, Takeda, velusetrag (TD-5108) / Innoviva
Safety and Efficacy of Highly Selective 5-HT4 Agonist (Velusetrag, Felcisetrag, Prucalopride) for Diabetic/Idiopathic Gastroparesis - Systematic Review and Meta-Analysis of Randomized Controlled Trials (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_2433;
Pooled GE time was also significantly better with 5-HT4 agonists (mean difference: 2.534, [1.695, 3.373], p< 0.05). Pooled rates of total adverse events were greater with 5-HT4 agonists (mean difference: 6.975, [1.042, 46.684], p< 0.05).
- || felcisetrag (TAK-954) / Takeda
PK/PD data, Journal: The Effect of Hepatic Impairment on the Pharmacokinetics of Intravenously Administered Felcisetrag (TAK-954). (Pubmed Central) - Jul 23, 2022
Infusions were well tolerated with no discontinuations, severe adverse events, or deaths during the study. Overall, the effect of hepatic impairment on exposure to felcisetrag was minimal, suggesting that dose adjustment may be unnecessary in patients with hepatic impairment.
- |||| felcisetrag (TAK-954) / Theravance Biopharma
Trial completion, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Jun 7, 2022
P2, N=210, Completed, Sponsor: Takeda
Overall, the effect of hepatic impairment on exposure to felcisetrag was minimal, suggesting that dose adjustment may be unnecessary in patients with hepatic impairment. Recruiting --> Completed
- | felcisetrag (TAK-954) / Takeda
Preclinical, Journal: Clinical and Nonclinical Disposition and In Vitro Drug-Drug Interaction Potential of Felcisetrag, a Highly Selective and Potent 5-HT Receptor Agonist. (Pubmed Central) - May 6, 2022
Felcisetrag is primarily cleared in humans through renal excretion. Although the metabolism of felcisetrag is primarily through CYP3A, the potential for clinically relevant DDI as a victim is significantly reduced as metabolism plays a minor role in the overall clearance.
- || felcisetrag (TAK-954) / Takeda
PK/PD data, Journal: Evaluation of the Pharmacokinetics of Felcisetrag (TAK-954), a 5-HT Receptor Agonist, in the Presence and Absence of Itraconazole, a Potent CYP3A4 Inhibitor. (Pubmed Central) - Apr 5, 2022
P1
Peak exposure was similar between regimens (geometric mean ratio, 1.06; 90% confidence interval, 0.96-1.18), and both treatments were well tolerated. These data suggest limited CYP3A4-mediated drug-drug interaction inhibition for felcisetrag.
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial primary completion date, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Mar 16, 2022
P2, N=180, Recruiting, Sponsor: Takeda
These data suggest limited CYP3A4-mediated drug-drug interaction inhibition for felcisetrag. Trial primary completion date: Feb 2022 --> Jun 2022
- | felcisetrag (TAK-954) / Takeda
Journal: Editorial: felcisetrag-forward movement as a novel prokinetic for gastroparesis. (Pubmed Central) - May 25, 2021
Trial primary completion date: Feb 2022 --> Jun 2022 No abstract available
- ||| felcisetrag (TAK-954) / Theravance Biopharma
Enrollment change, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - May 6, 2021
P2, N=180, Recruiting, Sponsor: Takeda
No abstract available N=375 --> 180
- || felcisetrag (TAK-954) / Takeda
Clinical, P2a data, Journal: Blinded, Double-Dummy, Parallel-Group, Phase 2a Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Highly Selective 5-Hydroxytryptamine Type 4 Receptor Agonist in Critically Ill Patients With Enteral Feeding Intolerance. (Pubmed Central) - Mar 20, 2021
P1/2
N=375 --> 180 A single dose of 0.5 mg intravenous TAK-954 appears to have at least similar efficacy in accelerating gastric emptying to multiple doses of 10 mg metoclopramide and was not associated with increased AEs.
- || felcisetrag (TAK-954) / Takeda
Clinical, Journal: Randomised study: effects of the 5-HT receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis. (Pubmed Central) - Mar 13, 2021
P2
felcisetrag significantly accelerated gastric, small bowel and colonic transit in patients with gastroparesis, and should be further evaluated for short-term treatment of gastric and intestinal motility disorders. ClinicalTrials.gov #NCT03281577.
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial completion date, Trial primary completion date, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Feb 18, 2021
P2, N=375, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov #NCT03281577. Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Feb 2021 --> Feb 2022
- || Clinical, Review, Journal: Postoperative Ileus and Postoperative Gastrointestinal Tract Dysfunction: Pathogenic Mechanisms and Novel Treatment Strategies Beyond Colorectal Enhanced Recovery After Surgery Protocols. (Pubmed Central) - Jan 5, 2021
These include 5HTR agonists (Prucalopride and TAK 954), vagus nerve stimulation of the ENS-macrophage nAChR cholinergic pathway, acupuncture, herbal medications, peripheral acting opioid antagonists (Alvimopen, Methlnaltexone, Naldemedine), anti-bloating/flatulence drugs (Simethiocone), a ghreline prokinetic agonist (Ulimovelin), drinking coffee, and nicotine chewing gum. A better understanding of the pathogenic mechanisms for short and long-term outcomes is necessary before we can develop better prophylactic and treatment strategies.
- |||| felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Jun 17, 2020
P2, N=375, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
A better understanding of the pathogenic mechanisms for short and long-term outcomes is necessary before we can develop better prophylactic and treatment strategies. Active, not recruiting --> Recruiting
- ||| felcisetrag (TAK-954) / Theravance Biopharma
Enrollment closed, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Apr 20, 2020
P2, N=375, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- TAK-954 / Takeda
Beyond organic solvents: Synthesis of a 5-HT4 receptor agonist in water (Michael A Nutter Theatre, Pennsylvania Convention Center) - Feb 13, 2020 - Abstract #ACSSp2020ACS_Sp_14230;
We redeveloped the six-step TAK-954 manufacturing sequence to be run entirely in water, replacing five separate organic solvents used in the enabling route, while implementing five direct isolations from aqueous media. Key transformations carried out in aqueous media include a benzimidazole cyclization, amidation, reductive amination, and a selective oxidation of an aliphatic alcohol.
- TAK-954 / Takeda
A DOSE-RANGING, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECT OF TAK-954 ON GASTROINTESTINAL AND COLONIC TRANSIT IN PATIENTS WITH DIABETIC OR IDIOPATHIC GASTROPARESIS () - Jan 28, 2020 - Abstract #DDW2020DDW_2439;
TAK-954 was well tolerated. These results support further evaluation of TAK-954 for the treatment of gastric and intestinal motility disorders.
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial completion date, Trial primary completion date, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Jan 15, 2020
P2, N=375, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
These results support further evaluation of TAK-954 for the treatment of gastric and intestinal motility disorders. Trial completion date: Aug 2020 --> May 2021 | Trial primary completion date: May 2020 --> Feb 2021
- | felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Aug 26, 2019
P1, N=31, Completed, Sponsor: Takeda
Trial completion date: Aug 2020 --> May 2021 | Trial primary completion date: May 2020 --> Feb 2021 Recruiting --> Completed
- | felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants (clinicaltrials.gov) - Jul 24, 2019
P2, N=36, Completed, Sponsor: Takeda
Recruiting --> Completed Active, not recruiting --> Completed
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - Jun 12, 2019
P1, N=6, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Completed
- | felcisetrag (TAK-954) / Theravance Biopharma
Enrollment closed: Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants (clinicaltrials.gov) - Jun 12, 2019
P2, N=41, Active, not recruiting, Sponsor: Takeda
Recruiting --> Completed Recruiting --> Active, not recruiting
- || felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - Mar 26, 2019
P1, N=6, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||| felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Mar 26, 2019
P2, N=375, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open, Trial completion date, Trial primary completion date: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Mar 22, 2019
P1, N=31, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Completed --> Recruiting | Trial completion date: Dec 2018 --> May 2019 | Trial primary completion date: Nov 2018 --> Apr 2019
- || felcisetrag (TAK-954) / Theravance Biopharma
New P1 trial: A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - Mar 12, 2019
P1, N=6, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- ||||| felcisetrag (TAK-954) / Theravance Biopharma
New P2 trial, Surgery: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery (clinicaltrials.gov) - Feb 1, 2019
P2, N=375, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Dec 20, 2018
P1, N=31, Completed, Sponsor: Takeda
Completed --> Recruiting | Trial completion date: Dec 2018 --> May 2019 | Trial primary completion date: Nov 2018 --> Apr 2019 Active, not recruiting --> Completed
- | felcisetrag (TAK-954) / Theravance Biopharma
Trial completion date, Trial primary completion date: Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants (clinicaltrials.gov) - Dec 19, 2018
P2, N=48, Recruiting, Sponsor: Takeda
Active, not recruiting --> Completed Trial completion date: Dec 2018 --> May 2019 | Trial primary completion date: Dec 2018 --> May 2019
- | felcisetrag (TAK-954) / Theravance Biopharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI) (clinicaltrials.gov) - Dec 17, 2018
P2b, N=1, Terminated, Sponsor: Millennium Pharmaceuticals, Inc.
Trial completion date: Dec 2018 --> May 2019 | Trial primary completion date: Dec 2018 --> May 2019 N=200 --> 1 | Trial completion date: Jun 2019 --> Aug 2018 | Recruiting --> Terminated | Trial primary completion date: Jun 2019 --> Aug 2018; Insufficient enrollment; No safety concerns
- || felcisetrag (TAK-954) / Theravance Biopharma
Enrollment closed: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Dec 6, 2018
P1, N=31, Active, not recruiting, Sponsor: Takeda
N=200 --> 1 | Trial completion date: Jun 2019 --> Aug 2018 | Recruiting --> Terminated | Trial primary completion date: Jun 2019 --> Aug 2018; Insufficient enrollment; No safety concerns Recruiting --> Active, not recruiting
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954 (clinicaltrials.gov) - Sep 12, 2018
P1, N=25, Completed, Sponsor: Takeda
Recruiting --> Active, not recruiting Recruiting --> Completed
- || felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants (clinicaltrials.gov) - Jul 3, 2018
P1, N=6, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Completed Recruiting --> Completed
- ||| felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI) (clinicaltrials.gov) - Jun 21, 2018
P2b, N=200, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting
- felcisetrag (TAK-954) / Theravance Biopharma
New P1 trial: A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants (clinicaltrials.gov) - Apr 18, 2018
P1, N=6, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- |||||| felcisetrag (TAK-954) / Theravance Biopharma
New P2b trial: TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI) (clinicaltrials.gov) - Mar 27, 2018
P2b, N=200, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Jan 23, 2018
P1, N=40, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954 (clinicaltrials.gov) - Jan 16, 2018
P1, N=32, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants (clinicaltrials.gov) - Jan 9, 2018
P2, N=48, Recruiting, Sponsor: Takeda
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- felcisetrag (TAK-954) / Theravance Biopharma
Trial completion: A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - Nov 29, 2017
P1, N=10, Completed, Sponsor: Takeda
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- felcisetrag (TAK-954) / Theravance Biopharma
Trial primary completion date: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Oct 27, 2017
P1, N=40, Not yet recruiting, Sponsor: Takeda
Active, not recruiting --> Completed Trial primary completion date: Mar 2018 --> Jul 2018
- | felcisetrag (TAK-954) / Theravance Biopharma
New P1 trial: A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954 (clinicaltrials.gov) - Sep 27, 2017
P1, N=40, Not yet recruiting, Sponsor: Takeda
- | felcisetrag (TAK-954) / Theravance Biopharma
New P2 trial: Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants (clinicaltrials.gov) - Sep 13, 2017
P2, N=48, Not yet recruiting, Sponsor: Takeda
- | felcisetrag (TAK-954) / Theravance Biopharma
New P1 trial: A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954 (clinicaltrials.gov) - Sep 11, 2017
P1, N=32, Not yet recruiting, Sponsor: Takeda
- felcisetrag (TAK-954) / Theravance Biopharma
Enrollment closed: A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - Jul 18, 2017
P1, N=10, Active, not recruiting, Sponsor: Takeda
Trial primary completion date: Mar 2018 --> Jul 2018 Recruiting --> Active, not recruiting
- felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - Jun 5, 2017
P1, N=10, Recruiting, Sponsor: Takeda
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- felcisetrag (TAK-954) / Theravance Biopharma
New P1 trial: A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants (clinicaltrials.gov) - May 31, 2017
P1, N=10, Not yet recruiting, Sponsor: Takeda
- felcisetrag (TAK-954) / Theravance Biopharma
Trial completion, Enrollment change, Trial primary completion date: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance (clinicaltrials.gov) - Dec 19, 2014
P1/2, N=13, Completed, Sponsor: Theravance Biopharma R & D, Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed | N=60 --> 13 | Trial primary completion date: Oct 2015 --> Sep 2014
- |||| felcisetrag (TAK-954) / Theravance Biopharma
Enrollment open: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance (clinicaltrials.gov) - Jan 30, 2014
P1/2, N=60, Recruiting, Sponsor: Theravance, Inc.
Recruiting --> Completed | N=60 --> 13 | Trial primary completion date: Oct 2015 --> Sep 2014 Not yet recruiting --> Recruiting