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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: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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 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:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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: August 2012
Primary Completion Date: August 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
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: September 19, 2012
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 May 23, 2013