A Study of RO5267683 in Healthy Subjects

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO5267683

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01398241

BP25214

2011-000600-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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