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: August 26, 2014
Last verified: August 2014

January 19, 2012
August 26, 2014
January 2012
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01531647 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: danoprevir
    100 mg q12h Days 8-21
  • Drug: raltegravir
    400 mg q12h Days 1-4 and 18-21
  • Drug: ritonavir
    100 mg q12h Days 8-21
  • Active Comparator: Period 1 Control
    Intervention: Drug: raltegravir
  • Experimental: Period 2 danoprevir/ritonavir
    Interventions:
    • Drug: danoprevir
    • Drug: raltegravir
    • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01531647
NP28088
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP