A phase 1 open-label study to characterize the metabolism and excretion of a single dose of radiolabeled AL-335 administered in combination with Odalasvir and Simeprevir and administered alone in healthy male subjects
Withdrawn
- Conditions
- chronic hepatitis C infection.10047438
- Registration Number
- NL-OMON44638
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
healthy male subjects
18 - 55 years of age
BMI 18 - 30 kilograms/meter2
weight at least 50 kilograms
non smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to characterize the metabolic pathways<br /><br>of AL-335 and the routes of excretion of the compound and its metabolites,<br /><br>after single oral dosing of AL-335 in combination with ODV and SMV and after<br /><br>single oral dosing of AL-335 alone, in healthy male subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study is to determine the short-term<br /><br>pharmacokinetics (PK), safety, and tolerability of a single oral dose of<br /><br>radiolabeled (14C-)AL-335 administered in combination with ODV and SMV and<br /><br>administered alone, in healthy male subjects.</p><br>