A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: danoprevir (Drug); raltegravir (Drug); ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Summary
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.
Clinical Details
Official title: A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)
Secondary outcome: Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC)Safety: Incidence of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lenexa, Kansas 66219, United States
Additional Information
Starting date: January 2012
Last updated: August 17, 2015
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