Status:
COMPLETED
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in ...
Eligibility Criteria
Inclusion
- Healthy volunteers, 18-65 years of age
- Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
- In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception
Exclusion
- A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
- Clinical significant abnormalities in laboratory test results
- Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
- Smokers of \>5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01209221
Start Date
September 1 2010
End Date
October 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
Christchurch, New Zealand, 8011