chronic hepatitis C infection.
Conditions
Interventions
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: healthy male subjects 18 - 55 years of age BMI 18 - 30 kilograms/meter2 weight at least 50 kilograms non smokers
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to characterize the metabolic pathways of AL-335 and the routes of excretion of the compound and its metabolites, after single oral dosing of AL-335 in combination with ODV and SMV and after single oral dosing of AL-335 alone, in healthy male subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to determine the short-term pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiolabeled (14C-)AL-335 administered in combination with ODV and SMV and administered alone, in healthy male subjects. | — |
Countries
Netherlands
Outcome results
None listed