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

NCT01588002 | Completed Phase 1

• 1 other identifier: NP28103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety: Incidence of adverse events

  approximately 2 months

Study Arms (3)

A danoprevir+ritonavir

ACTIVE COMPARATOR

Drug: danoprevir; Drug: ritonavir

B efavirenz

ACTIVE COMPARATOR

Drug: efavirenz

C combination

EXPERIMENTAL

Drug: danoprevir; Drug: efavirenz; Drug: ritonavir

Interventions

danoprevir DRUG

multiple oral doses

A danoprevir+ritonavir; C combination

efavirenz DRUG

multiple oral doses

B efavirenz; C combination

ritonavir DRUG

multiple oral doses

A danoprevir+ritonavir; C combination

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

danoprevir; efavirenz; Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)