A Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6799477 Following Oral Administration of Single Ascending Doses in Healthy Volunteers.

Hoffmann-La Roche0 sites27 target enrollmentJuly 2013

ConditionsHealthy Volunteer

InterventionsRO6799477

DrugsRO6799477

Overview

Phase: Phase 1
Intervention: RO6799477
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 27
Primary Endpoint: Part 1: Safety: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

October 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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