A Study of RO6799477 in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO6799477

Study type: Interventional

Funder types: Industry

Identifiers

NCT01893437

2013-000402-28 (EudraCT Number)

BP28751

Details and patient eligibility

About

This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

27 participants in 1 patient group

Single oral dose group

Experimental group

Treatment:

Drug: RO6799477