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A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 16, 2012
Last updated: November 1, 2016
Last verified: November 2016
This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.

Condition Intervention Phase
Healthy Volunteer Drug: cyclosporine Drug: danoprevir Drug: ritonavir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Drug-Drug Interaction Study Between Danoprevir/Low-dose Ritonavir and Cyclosporine, a Potent Inhibitor of OATP, in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC) [ Time Frame: 16 time points up to 96 hours ]

Secondary Outcome Measures:
  • Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine [ Time Frame: 16 time points up to 96 hours ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 50 days ]

Enrollment: 18
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DNV/r+cyclosporine Drug: cyclosporine
Single oral dose
Drug: danoprevir
Single oral dose
Drug: ritonavir
Single oral dose
Active Comparator: cyclosporine Drug: cyclosporine
Single oral dose
Active Comparator: danoprevir+ritonavir Drug: danoprevir
Single oral dose
Drug: ritonavir
Single oral dose


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and female healthy volunteers, 18 to 45 years of age inclusive
  • Body mass index (BMI) 18.0 to 32.0 kg/m2
  • Weight >/= 50 kg
  • Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
  • Nonsmoker
  • Females of childbearing potential and males and their female partner(s) 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 (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)

Exclusion Criteria:

  • Pregnant or lactating females
  • Positive results for drugs of abuse in the urine 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 the first dose of study medication
  • Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
  • Routine chronic use of more than 2 g acetaminophen daily
  • Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
  • History of clinically significant disease or disorder
  • History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01514968

United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01514968     History of Changes
Other Study ID Numbers: NP27947
Study First Received: January 16, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Bacterial Agents processed this record on August 18, 2017