Status:
COMPLETED
A Study of RO5267683 in Healthy Subjects
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 volunte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01398241
Start Date
August 1 2011
End Date
June 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Strasbourg, France, 67064