A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592305
First received: April 24, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: danoprevir Drug: ritonavir Drug: tenofovir disoproxil fumarate Drug: atazanavir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Formic acid
Tenofovir
Ritonavir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20 ] [ Designated as safety issue: No ]
- Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | May 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: S1 P1 TDF + DNV/r |
Drug: danoprevir
multiple oral doses
Drug: ritonavir
multiple oral doses
Drug: tenofovir disoproxil fumarate
single oral doses
|
| Experimental: S2 P1 ATZ/r |
Drug: ritonavir
multiple oral doses
Drug: atazanavir
multiple oral doses
|
| Experimental: S1/S2 P2 DNV/r + ATZ |
Drug: danoprevir
multiple oral doses
Drug: ritonavir
multiple oral doses
Drug: atazanavir
multiple oral doses
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01592305 History of Changes |
| Other Study ID Numbers: | NP28104 |
| Study First Received: | April 24, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ritonavir Atazanavir Tenofovir Tenofovir disoproxil HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013