A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592318
First received: April 24, 2012
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: danoprevir Drug: ritonavir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | An Up to Two-Part Relative Bioavailability Study of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets as Compared to the Reference Phase 2 Ad Hoc Combination Tablets in Healthy Adult Volunteers |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 ] [ Designated as safety issue: No ]
- Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DNV/r fixed dose combination |
Drug: danoprevir
Fixed dose combination tablet with ritonavir, single oral dose
Drug: ritonavir
Fixed dose combination tablet with danoprevir, single oral dose
|
| Active Comparator: DNV + r reference |
Drug: danoprevir
Reference tablet, single oral dose
Drug: ritonavir
Reference tablet, single oral dose
|
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
- Body weight >/= 50.0 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 cardiovascular or cerebrovascular disease, hypertension, and/or infections
- Positive result for drugs of abuse 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 first dose of study medication
- Use of hormonal contraceptives (e.g. birth control pills, patches, 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 allergic reactions or hepatotoxicity
- 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: | NCT01592318 History of Changes |
| Other Study ID Numbers: | NP28136 |
| Study First Received: | April 24, 2012 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ritonavir Lactams 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 Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013