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

Study Timeline

• Study First Submitted: 2013-06-27
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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

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

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