A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers

NCT01592318 | Completed Phase 1

• 1 other identifier: NP28136
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC)

  Pre-dose and up to 24 hours post-dose Days 1, 8 and 15

• Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)

  Pre-dose and up to 24 hours post-dose Days 1, 8 and 15

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 2 months

Study Arms (2)

DNV + r reference

ACTIVE COMPARATOR

Drug: danoprevir; Drug: ritonavir

DNV/r fixed dose combination

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Interventions

danoprevir DRUG

Fixed dose combination tablet with ritonavir, single oral dose

DNV/r fixed dose combination

ritonavir DRUG

Fixed dose combination tablet with danoprevir, single oral dose

DNV/r fixed dose combination

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female volunteers, 18 to 55 years of age
• Body weight \>/= 50.0 kg
• Body mass index (BMI) 18.0 - 32.0 kg/m2
• Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
• 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, 1 of which must be a barrier method, 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
• Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
• Positive result 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 (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication
• Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
• History of drug-related allergic reactions or hepatotoxicity
• History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: May 7, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (1)