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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01514968
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: cyclosporine Drug: danoprevir Drug: ritonavir Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : December 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine [ Time Frame: 16 time points up to 96 hours ]
  2. Safety: Incidence of adverse events [ Time Frame: approximately 50 days ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01514968     History of Changes
Other Study ID Numbers: NP27947
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 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