A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01588002

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

A Study to Evaluate the Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir When Administered Together in Healthy Adult Volunteers

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A danoprevir+ritonavir	Drug: danoprevir multiple oral doses Drug: ritonavir multiple oral doses
Active Comparator: B efavirenz	Drug: efavirenz multiple oral doses
Experimental: C combination	Drug: danoprevir multiple oral doses Drug: efavirenz multiple oral doses Drug: ritonavir multiple oral doses

Arm

Intervention/Treatment

Active Comparator: A danoprevir+ritonavir

Drug: danoprevir

multiple oral doses

Drug: ritonavir

multiple oral doses

Active Comparator: B efavirenz

Drug: efavirenz

multiple oral doses

Experimental: C combination

Drug: danoprevir

multiple oral doses

Drug: efavirenz

multiple oral doses

Drug: ritonavir

multiple oral doses

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Cmax [Pre-dose and up to 24 hours post-dose on Days 14 and 28]
Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Area under the concentration-time curve (AUC) [Pre-dose and up to 24 hours post-dose on Days 14 and 28]

Secondary Outcome Measures

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 male and female non-smoking subjects, 18 to 55 years of age
Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
Medical history without major, recent or ongoing pathology
Weight >/= 50.0 kg
Body mass index (BMI) 18.0 - 32.0 kg/m2

Exclusion Criteria:

Pregnant or lactating women or males with female partners who are pregnant or lactating
History of any clinically significant medical condition which may impact the safety of the participant
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
Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
Use of hormonal contraceptives (e.g. birth control pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
Use of investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
History of drug-related allergic reaction
History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average; alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study

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:

NCT01588002

Other Study ID Numbers:

NP28103

First Posted:

Apr 30, 2012

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Ritonavir

Efavirenz

Study Results

No Results Posted as of Nov 2, 2016