Status:
COMPLETED
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ...
Eligibility Criteria
Inclusion
- Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Female subject must be post-menopausal or surgically sterile
- Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug
Exclusion
- History of any clinically significant disease or disorder
- Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Clinically significant abnormalities in laboratory test results
- Suspicion of regular consumption of drug of abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug or device study within 90 days prior to screening
- Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
- History of clinically significant hypersensitivity or allergic drug reactions
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01864226
Start Date
June 1 2013
End Date
January 1 2014
Last Update
November 2 2016
Active Locations (1)
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1
Zuidlaren, Netherlands, 9471 GP