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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01588002
First received: April 19, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crosso ver study will evaluate potential drug-drug interaction between efavirenz and da noprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects wi ll be randomized to receive multiple oral doses of either danoprevir with ritona vir or efavirenz for 14 days. In Period 2, all subjects will receive multiple or al doses of the combination danoprevir with ritonavir and efavirenz for 14 days.

Anticipated time on study treatment is 28 days.


Condition Intervention Phase
Healthy Volunteer
Drug: danoprevir
Drug: efavirenz
Drug: ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Cmax [ Time Frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588002

Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01588002     History of Changes
Other Study ID Numbers: NP28103
Study First Received: April 19, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Efavirenz
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014