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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01531647
First received: January 19, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label, multiple dose, single sequence crossover study will evaluate th e 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 com bination with raltegravir on Days 18-21.


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

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose Days 8. 14, 15, 16 and 20, pre-and up to 24 h post-dose Days 17 and 21 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: ritonavir
100 mg q12h Days 8-21
Drug: raltegravir
400 mg q12h Days 1-4 and 18-21

  Eligibility

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

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
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: NCT01531647

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: NCT01531647     History of Changes
Other Study ID Numbers: NP28088
Study First Received: January 19, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014