Status:
COMPLETED
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be random...
Eligibility Criteria
Inclusion
- Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
- Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
- Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose
Exclusion
- Suspicion of regular consumption of drugs of abuse
- Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
- Positive for hepatitis B, hepatitis C or HIV infection
- History of hypersensitivity or severe drug reaction
- Participation in an investigational drug or device study within three months before the first drug administration
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01461967
Start Date
September 1 2011
End Date
December 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
Strasbourg, France, 67064