A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01483729
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 6
• Duration (Months): 1
• Patients Per Site Per Month: 35.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir; Drug: danoprevir; Drug: danoprevir; Drug: ritonavir; Drug: ritonavir; Drug: ritonavir	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) [24 hours]

2. Part 1: Danoprevir bioavailability (Tablet Formulation 2) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC) [24 hours]

3. Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC) [24 hours]

4. Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC) [24 hours]

Secondary Outcome Measures

1. Safety: Incidence of adverse events [approximately 4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Christchurch		New Zealand	8011

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01483729
• Other Study ID Numbers: NP27945; RPU425UD-114254
• First Posted: Dec 1, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ritonavir; Lactams

Study Results

No Results Posted as of Nov 2, 2016