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

NCT01592305 | Completed Phase 1

• 1 other identifier: NP28104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 2 months

Study Arms (3)

S1 P1 TDF + DNV/r

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir; Drug: tenofovir disoproxil fumarate

S1/S2 P2 DNV/r + ATZ

EXPERIMENTAL

Drug: atazanavir; Drug: danoprevir; Drug: ritonavir

S2 P1 ATZ/r

EXPERIMENTAL

Drug: atazanavir; Drug: ritonavir

Interventions

atazanavir DRUG

multiple oral doses

S1/S2 P2 DNV/r + ATZ; S2 P1 ATZ/r

danoprevir DRUG

multiple oral doses

S1 P1 TDF + DNV/r; S1/S2 P2 DNV/r + ATZ

ritonavir DRUG

multiple oral doses

S1 P1 TDF + DNV/r; S1/S2 P2 DNV/r + ATZ; S2 P1 ATZ/r

tenofovir disoproxil fumarate DRUG

single oral doses

S1 P1 TDF + DNV/r

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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Atazanavir Sulfate; danoprevir; Ritonavir; Tenofovir

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Intervention Model: PARALLEL
• 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

US (1)