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

Healthy Volunteer Clinical Trial

Official title:

An Up to Two-Part Relative Bioavailability Study of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets as Compared to the Reference Phase 2 Ad Hoc Combination Tablets in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592318
• Other study ID #: NP28136
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2012
• Last updated: November 1, 2016
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• danoprevir
Fixed dose combination tablet with ritonavir, single oral dose
• danoprevir
Reference tablet, single oral dose
• ritonavir
Fixed dose combination tablet with danoprevir, single oral dose
• ritonavir
Reference tablet, 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	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	No
Primary	Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC)		Pre-dose and up to 24 hours post-dose Days 1, 8 and 15	No
Secondary	Safety: Incidence of adverse events		approximately 2 months	No