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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01531647

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir Drug: raltegravir Drug: ritonavir	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

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 Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Period 1 Control	Drug: raltegravir 400 mg q12h Days 1-4 and 18-21
Experimental: Period 2 danoprevir/ritonavir	Drug: danoprevir 100 mg q12h Days 8-21 Drug: raltegravir 400 mg q12h Days 1-4 and 18-21 Drug: ritonavir 100 mg q12h Days 8-21

Arm

Intervention/Treatment

Active Comparator: Period 1 Control

Drug: raltegravir

400 mg q12h Days 1-4 and 18-21

Experimental: Period 2 danoprevir/ritonavir

Drug: danoprevir

100 mg q12h Days 8-21

Drug: raltegravir

400 mg q12h Days 1-4 and 18-21

Drug: ritonavir

100 mg q12h Days 8-21

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lenexa	Kansas	United States	66219

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01531647

Other Study ID Numbers:

NP28088

First Posted:

Feb 13, 2012

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Ritonavir

Raltegravir Potassium

Study Results

No Results Posted as of Nov 2, 2016