A Study of RO6799477 in Healthy Volunteers

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01893437

Enrollment

Registered

2013-07-09

Start date

2013-07-31

Completion date

2013-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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

Interventions

DRUGRO6799477

Single doses of RO6799477

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Part 1: Safety: Incidence of adverse events	18 weeks

Secondary

Measure	Time frame
Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477	Pre-dose, Day 1, 2, 3, 4

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026