A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

Healthy Volunteer Clinical Trial

Official title:

A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir When Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592305
• Other study ID #: NP28104
• 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, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• 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, inclusive

• Body weight >/= 55 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 disease or condition

• Positive for drugs of abuse at screening or prior to admission to the clinical site

• 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 pill, patches, or 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 allergy reaction

• History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• atazanavir
multiple oral doses
• danoprevir
multiple oral doses
• ritonavir
multiple oral doses
• tenofovir disoproxil fumarate
single oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC)		Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20	No
Primary	Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC)		Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20	No
Secondary	Safety: Incidence of adverse events		approximately 2 months	No