AL-335
Sponsors
Alios Biopharma Inc., Janssen Research & Development, LLC, Janssen Pharmaceutical K.K.
Conditions
Chronic Hepatitis CHealthyHepatitis C, ChronicRenal Insufficiency
Phase 1
First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
CompletedNCT02339207
Start: 2014-12-31End: 2016-05-31Updated: 2019-10-16
A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers
CompletedNCT02512562
Start: 2015-07-31End: 2015-08-31Updated: 2019-10-16
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
CompletedNCT02821858
Start: 2016-06-14End: 2016-09-30Updated: 2018-03-29
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
CompletedNCT02824315
Start: 2016-05-31End: 2016-10-31Updated: 2025-02-03
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
CompletedNCT02885454
Start: 2016-08-31End: 2016-12-31Updated: 2017-01-23
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
CompletedNCT02894905
Start: 2016-09-13End: 2017-08-16Updated: 2017-12-20
Phase 2
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
CompletedNCT02569710
Start: 2015-10-31End: 2018-05-11Updated: 2019-07-16
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
CompletedNCT02765490
Start: 2016-11-09End: 2017-11-16Updated: 2019-11-20
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
CompletedNCT02993250
Start: 2016-12-21End: 2018-05-07Updated: 2019-09-11