A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 8/3/2016 |
Start Date: | January 2012 |
End Date: | March 2012 |
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers
This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug
interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers.
Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days,
danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days
18-21.
interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers.
Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days,
danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days
18-21.
Inclusion Criteria:
- Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
- Healthy status defined by absence of evidence of any active or chronic disease
- Medical history without major, recent, or ongoing pathology
- Weight >/= 50.0 kg
- Body mass index (BMI) 18.0 - 32-0 kg/m2
- Willingness to abstain from alcohol, xanthine-containing beverages or food (e.g.
coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the
clinical site until discharge
- Females of child-bearing potential and males and their female partners of
child-bearing potential must agree to use 2 forms of contraception, one of which must
be a barrier method, during the study and for 90 days after the last drug
administration. Acceptable barrier forms of contraception are condom and diaphragm;
acceptable non-barrier forms of contraception for this study are non-hormonal
intrauterine device (IUD) and/or spermicide
Exclusion Criteria:
- Pregnant or lactating females or males with female partners who are pregnant or
lactating
- Any history of clinically significant cardiovascular or cerebrovascular disease,
hypertension, and/or infections
- Positive test 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
- Current smokers or subjects who have discontinued smoking less than 6 months prior to
first dose of study medication
- Use of hormonal contraceptives within 30 days before the first dose of study
medication
- History of clinically significant drug-related allergy (such as anaphylaxis) or
hepatotoxicity
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