A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

NCT01483729 | Completed Phase 1

• 2 other identifiers: NP27945RPU425UD-114254
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• Part 1: Danoprevir bioavailabilty (Tablet Formulation 1) in combination with ritonavir (reference formulation): Area under the concentration-time curve (AUC)

  24 hours

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

  24 hours

• Part 2: Ritonavir bioavailability (Test Formulation 1) in combination with danoprevir (refernce formulation): Area under the concentration-time curve (AUC)

  24 hours

• Part 2: Ritonavir bioavailability (Test Formulation 2) in combination with danoprevir (reference formulation): Area under the concentration-time curve (AUC)

  24 hours

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 4 months

Study Arms (6)

Part 1 A

ACTIVE COMPARATOR

Drug: danoprevir; Drug: ritonavir

Part 1 B

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Part 1 C

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Part 2 D

ACTIVE COMPARATOR

Drug: danoprevir; Drug: ritonavir

Part 2 E

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Part 2 F

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Interventions

danoprevir DRUG

Phase 3 Tablet Formulation 1, single oral dose

Part 1 B

ritonavir DRUG

Test Formulation 1, single oral dose

Part 2 E

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

danoprevir; Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 1, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (1)