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

NCT ID: NCT01514968

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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DNV/r+cyclosporine

Group Type EXPERIMENTAL

cyclosporine

Intervention Type DRUG

Single oral dose

danoprevir

Intervention Type DRUG

Single oral dose

ritonavir

Intervention Type DRUG

Single oral dose

cyclosporine

Group Type ACTIVE_COMPARATOR

cyclosporine

Intervention Type DRUG

Single oral dose

danoprevir+ritonavir

Group Type ACTIVE_COMPARATOR

danoprevir

Intervention Type DRUG

Single oral dose

ritonavir

Intervention Type DRUG

Single oral dose

Interventions

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cyclosporine

Single oral dose

Intervention Type DRUG

danoprevir

Single oral dose

Intervention Type DRUG

ritonavir

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Lenexa, Kansas, United States

Site Status

Countries

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United States

References

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Brennan BJ, Moreira SA, Morcos PN, Navarro MT, Asthappan J, Goelzer P, Weigl P, Smith PF. Pharmacokinetics of a three-way drug interaction between danoprevir, ritonavir and the organic anion transporting polypeptide (OATP) inhibitor ciclosporin. Clin Pharmacokinet. 2013 Sep;52(9):805-13. doi: 10.1007/s40262-013-0077-2.

Reference Type DERIVED
PMID: 23712757 (View on PubMed)

Other Identifiers

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NP27947

Identifier Type: -

Identifier Source: org_study_id