Status:
COMPLETED
A Study of RO5285119 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volu...
Eligibility Criteria
Inclusion
- Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)
- Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
- Female subjects must be surgically sterile or postmenopausal
- Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing
Exclusion
- History or presence of any significant disease or disorder
- Positive for hepatitis B. hepatitis C or HIV infection
- History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse
- Participation in an investigational drug or device study within 3 months prior to first dosing
- Donation of blood within 3 months prior to first dosing
- Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day)
- History of hypersensitivity or allergic reactions
- Part 2: Contraindications for MRI scans
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01418963
Start Date
July 1 2011
End Date
July 1 2012
Last Update
November 2 2016
Active Locations (2)
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1
Rennes, France, 35042
2
Strasbourg, France, 67064