Odalasvir
- Generic Name
- Odalasvir
- Drug Type
- Small Molecule
- Chemical Formula
- C60H72N8O6
- CAS Number
- 1415119-52-6
- Unique Ingredient Identifier
- OVR52K7BDW
- Background
Odalasvir has been used in trials studying the treatment of Hepatitis C, Chronic and Chronic Hepatitis C Infection.
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)
Phase 1
Terminated
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2017-02-23
- Last Posted Date
- 2017-12-22
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 72
- Registration Number
- NCT03059303
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
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
Phase 2
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- First Posted Date
- 2016-12-15
- Last Posted Date
- 2019-09-11
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 33
- Registration Number
- NCT02993250
A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
- First Posted Date
- 2016-11-11
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 16
- Registration Number
- NCT02961660
- Locations
- 🇺🇸
New Orleans Center for Clinical Research, Knoxville, Tennessee, United States
🇺🇸Orlando Clinical Research Center, Orlando, Florida, United States
A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2016-10-26
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 15
- Registration Number
- NCT02945020
A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2016-09-05
- Last Posted Date
- 2017-04-10
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 60
- Registration Number
- NCT02889367
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2016-08-31
- Last Posted Date
- 2017-01-23
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 24
- Registration Number
- NCT02885454
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
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2016-07-06
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 22
- Registration Number
- NCT02824315
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
- First Posted Date
- 2016-07-04
- Last Posted Date
- 2018-03-29
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 40
- Registration Number
- NCT02821858
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
Phase 2
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- First Posted Date
- 2016-05-06
- Last Posted Date
- 2019-11-20
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 365
- Registration Number
- NCT02765490
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
Phase 2
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- First Posted Date
- 2015-10-07
- Last Posted Date
- 2019-07-16
- Lead Sponsor
- Alios Biopharma Inc.
- Target Recruit Count
- 161
- Registration Number
- NCT02569710
- Locations
- 🇬🇧
NHS Greater Glasgow and Clyde Glasgow Royal Infirmary, Glasgow, United Kingdom
🇬🇧Pennine Acute Hospitals Trust, Oldham, United Kingdom
🇳🇿Auckland Clinical Studies, Auckland, New Zealand
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