Status:
COMPLETED
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequ...
Eligibility Criteria
Inclusion
- Male healthy volunteers, 18-45 years of age inclusive
- Healthy as determined by screening assessments
- Body mass index (BMI) between 18-30 kg/m2
Exclusion
- Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
- History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
- Any history of alcohol and/or drug of abuse addiction during the past 5 years
- Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
- Any clinically relevant abnormal test results prior to first dosing
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01802853
Start Date
May 1 2013
End Date
June 1 2013
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leeds, United Kingdom, LS2 9LH