A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

Healthy Volunteer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483729
• Other study ID #: NP27945
• Secondary ID: RPU425UD-114254
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2011
• Last updated: November 1, 2016
• Start date: December 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses 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, subjects will be randomized to receive single oral doses of one of three tablet formulations 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
Phase 3 Tablet Formulation 1, single oral dose
• danoprevir
Phase 3 Tablet Formulation 2, single oral dose
• danoprevir
Reference Phase 2 Tablet Formulation, single oral dose
• ritonavir
Test Formulation 1, single oral dose
• ritonavir
Test Formulation 2, single oral dose
• ritonavir
Reference Formulation, single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)		24 hours	No
Primary	Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)		24 hours	No
Primary	Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC)		24 hours	No
Primary	Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC)		24 hours	No
Secondary	Safety: Incidence of adverse events		approximately 4 months	No