A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers

A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531647

Enrollment

Registered

2012-02-13

Start date

2012-01-31

Completion date

2012-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief 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.

Interventions

DRUGdanoprevir

100 mg q12h Days 8-21

DRUGraltegravir

400 mg q12h Days 1-4 and 18-21

DRUGritonavir

100 mg q12h Days 8-21

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)	approximately 2 months

Secondary

Measure	Time frame
Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC)	Pre-dose Days 8. 14, 15, 16 and 20, pre-and up to 24 h post-dose Days 17 and 21
Safety: Incidence of adverse events	approximately 2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026