A Study of RO5267683 in Healthy Subjects

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398241

Enrollment

Registered

2011-07-20

Start date

2011-08-31

Completion date

2012-06-30

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 investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

Interventions

DRUGRO5267683

Multiple ascending doses

DRUGplacebo

Multiple ascending doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects, 18 to 45 years of age, * Body mass index (BMI) 18 to 30 kg/m2 inclusive, and a minimum weight of 50 kg at screening * Female subjects must be surgically sterile or post-menopausal * Male subjects must use a barrier method of contraception for the duration of the study and for 90 days after the last dose

Exclusion criteria

* History or evidence of any clinically significant disease or disorder * Administration of an investigational drug or device within 3 months prior to dosing on Day 1 * Positive for hepatitis B, hepatitis C or HIV at screening * Subjects on hormone replacement therapy who have not been receiving a stable dose for at least 2 months prior to start of dosing

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	14 weeks

Secondary

Measure	Time frame
Pharmacokinetics: Plasma concentrations	14 weeks
Pharmacokinetics: Urine concentrations	4 weeks
Lipid levels in the blood	14 weeks

Countries

France

Outcome results

None listed

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