Status:
COMPLETED
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will b...
Eligibility Criteria
Inclusion
- Healthy volunteers, 18 to 45 years of age inclusive
- Body mass index 18.0 - 32.0 kg/m2, weight \>/= 50 kg
- Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Non-smoker
- Medical history without major, recent or ongoing pathology
- Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration
Exclusion
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
- Positive for hepatitis B, hepatitis C or HIV infection
- Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
- Routine use of more than 2 g of acetaminophen daily
- History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
- History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
- Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01483729
Start Date
December 1 2011
End Date
January 1 2012
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Christchurch, New Zealand, 8011