A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
Study Details
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 |
|---|---|---|
| Phase 1 |
Study Design
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
- Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC) [16 time points up to 96 hours]
Secondary Outcome Measures
- Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine [16 time points up to 96 hours]
- Safety: Incidence of adverse events [approximately 50 days]
Eligibility Criteria
Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NP27947