A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483729
First received: November 30, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in health y volunteers. In Part 1, subjects will be randomized to receive single oral dose s of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subject s will be randomized to receive single oral doses of one of three tablet formula tions of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part 1 A Drug: danoprevir
Reference Phase 2 Tablet Formulation, single oral dose
Drug: ritonavir
Reference Formulation, single oral dose
Experimental: Part 1 B Drug: danoprevir
Phase 3 Tablet Formulation 1, single oral dose
Drug: ritonavir
Reference Formulation, single oral dose
Experimental: Part 1 C Drug: danoprevir
Phase 3 Tablet Formulation 2, single oral dose
Drug: ritonavir
Reference Formulation, single oral dose
Active Comparator: Part 2 D Drug: danoprevir
Reference Phase 2 Tablet Formulation, single oral dose
Drug: ritonavir
Reference Formulation, single oral dose
Experimental: Part 2 E Drug: danoprevir
Reference Phase 2 Tablet Formulation, single oral dose
Drug: ritonavir
Test Formulation 1, single oral dose
Experimental: Part 2 F Drug: danoprevir
Reference Phase 2 Tablet Formulation, single oral dose
Drug: ritonavir
Test Formulation 2, single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, 18 to 45 years of age inclusive
  • Body mass index 18.0 - 32.0 kg/m2, weight >/= 50 kg
  • Healthy status will be defined as absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
  • Non-smoker
  • Medical history without major, recent or ongoing pathology
  • Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception (barrier form plus intrauterine device and spemicide) during the study and for 90 days after the last drug administration

Exclusion Criteria:

  • Pregnant or lactating women or males with female partners who are pregnant or lactating
  • 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
  • Use of hormonal contraceptives (birth control pills, injectable, implantable devices) within 30 days before the first dose of study medication
  • Routine use of more than 2 g of acetaminophen daily
  • History of clinically significant drug allergy (such as anaphylaxis) or hepatotoxicity
  • History of hypersensitivity to danoptevir, ritonavir, or other protease inhibitors
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
  • Current enrollment or participation in a clinical trial of an experimental medication or medical device within 3 months of screening unless agreed upon by the Sponsor
  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: NCT01483729

Locations
New Zealand
Christchurch, New Zealand, 8011
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: NCT01483729     History of Changes
Other Study ID Numbers: NP27945, RPU425UD-114254
Study First Received: November 30, 2011
Last Updated: July 7, 2014
Health Authority: New Zealand: Medsafe

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 23, 2014