JNJ-4178 / Medivir, J&J, AstraZeneca  >>  Phase 1
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6 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
JNJ-4178 / J&J
NCT02512562: A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

Completed
1
32
Europe
AL-335, ACH-3102, Simeprevir, Olysio
Alios Biopharma Inc., Alexion Pharmaceuticals
Chronic Hepatitis C
08/15
08/15
NCT02824315: Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants

Completed
1
22
Europe
AL-335, Odalasvir (ODV), Simeprevir (SMV)
Janssen Research & Development, LLC
Healthy
10/16
10/16
NCT02885454: To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

Completed
1
24
US
Drospirenone/ethinylestradiol, Yaz®, AL-335, Odalasvir (ODV), Simeprevir (SMV)
Janssen Research & Development, LLC
Healthy
12/16
12/16
NCT03059303: Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)

Terminated
1
72
US
Simeprevir 75 mg, Odalasvir 25 mg, Odalasvir 12.5 mg, Odalasvir 75 mg, AL-335 800 mg, Lansoprazole 30 mg, Prevacid, Omeprazole 20 mg
Janssen Research & Development, LLC
Healthy
04/17
04/17
NCT03155893: A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants

Completed
1
59
US
ODV Placebo (Matching 25 mg ODV), ODV Placebo (Matching 200 mg ODV), ODV Placebo (Matching 125 mg ODV), ODV Placebo (Matching 100 mg ODV), SMV Placebo (Matching 150 mg SMV), AL-335 Placebo (matching 1200 mg AL-335), Moxifloxacin Placebo (matching 400 mg moxifloxacin), ODV 25 mg, ODV 200 mg, ODV 125 mg, ODV 100 mg, SMV 150 mg, AL-335 1200 mg
Janssen Research & Development, LLC
Healthy
10/17
10/17
NCT03277755: A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function

Withdrawn
1
0
NA
AL-335 800 mg, JNJ-64146212, ODV 25 mg, JNJ-64289901, SMV 75 mg
Janssen Research & Development, LLC
Hepatic Impairment
12/17
12/17

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