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10 News |  |
- | AMG 333 / Amgen
Clinical, Journal: Discovery of TRPM8 Antagonist (S)-6-(((3-fluoro-4-(trifluoromethoxy)phenyl)(3-fluoropyridin-2-yl)methyl)carbamoyl)nicotinic acid (AMG 333), a Clinical Candidate for the Treatment of Migraine. (Pubmed Central) - Oct 16, 2019
This disclosure focuses on medicinal chemistry efforts to im-prove drug-like properties of initial leads, particularly removal of CYP3A4 induction liability and improvement of PK properties. A novel series of biarylmethanamide TRPM8 antagonists was developed, and a subset of leads were evaluated in preclinical toxicology studies to identify a clinical candidate with acceptable preclinical safety pro-file leading to clinical candidate AMG 333, a potent and highly selective antagonist of TRPM8 which was evaluated in human clinical trials.
- AMG 333 / Amgen
Enrollment change: Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects (clinicaltrials.gov) - Apr 14, 2015
P1, N=16, Terminated, Sponsor: Amgen
A novel series of biarylmethanamide TRPM8 antagonists was developed, and a subset of leads were evaluated in preclinical toxicology studies to identify a clinical candidate with acceptable preclinical safety pro-file leading to clinical candidate AMG 333, a potent and highly selective antagonist of TRPM8 which was evaluated in human clinical trials. N=48 --> 16
- AMG 333 / Amgen
Trial termination: Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects (clinicaltrials.gov) - Jan 30, 2015
P1, N=48, Terminated, Sponsor: Amgen
N=48 --> 16 Recruiting --> Terminated; The study was stopped due to an administrative decision not safety.
- ||| AMG 333 / Amgen
Trial completion: Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines (clinicaltrials.gov) - Dec 10, 2014
P1, N=74, Completed, Sponsor: Amgen
Recruiting --> Terminated; The study was stopped due to an administrative decision not safety. Active, not recruiting --> Completed
- || AMG 333 / Amgen
Enrollment closed: Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines (clinicaltrials.gov) - Nov 5, 2014
P1, N=74, Active, not recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- AMG 333 / Amgen
Enrollment open: Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects (clinicaltrials.gov) - May 26, 2014
P1, N=48, Recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || AMG 333 / Amgen
Trial primary completion date: Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines (clinicaltrials.gov) - May 21, 2014
P1, N=80, Recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Trial primary completion date: May 2014 --> Jul 2014
- | AMG 333 / Amgen
New P1 trial: Phase I, Double-Blind,Placebo, MAD Study to Evaluate the Safety, Tolerability, PK, and PD of AMG 333 in Healthy Subjects and Migraine Subjects (clinicaltrials.gov) - May 5, 2014
P1, N=48, Not yet recruiting, Sponsor: Amgen
- ||| AMG 333 / Amgen
Enrollment open: Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines (clinicaltrials.gov) - Jan 16, 2014
P1, N=80, Recruiting, Sponsor: Amgen
Trial primary completion date: May 2014 --> Jul 2014 Not yet recruiting --> Recruiting
- ||| AMG 333 / Amgen
New P1 trial: Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines (clinicaltrials.gov) - Sep 26, 2013
P1, N=80, Recruiting, Sponsor: Amgen