A Study of RO6799477 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: RO6799477
- Registration Number
- NCT01893437
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
Inclusion Criteria
- Male healthy volunteers, aged 18-45 years, inclusive
- Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.
- Body Mass index (BMI) of 18-30 kg/m2, inclusive
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Exclusion Criteria
- Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C
- Positive testing for drugs of abuse
- Any history of alcohol and/or drug of abuse addiction
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single oral dose group RO6799477 -
- Primary Outcome Measures
Name Time Method Part 1: Safety: Incidence of adverse events 18 weeks
- Secondary Outcome Measures
Name Time Method Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477 Pre-dose, Day 1, 2, 3, 4