Lenexa, Kansas, 66219, United States
NCT Number: NCT01588002
A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers
This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy male and female non-smoking subjects, 18 to 55 years of age
- 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
- Weight >/= 50.0 kg
- Body mass index (BMI) 18.0 - 32.0 kg/m2
Exclusion criteria
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- History of any clinically significant medical condition which may impact the safety of the participant
- Positive results 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 pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
- Use of 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 reaction
- History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average; alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study
Treatment and study plan
Danoprevir
Drugmultiple oral doses
Efavirenz
Drugmultiple oral doses
Ritonavir
Drugmultiple oral doses
Primary outcomes
-
Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Cmax
Time frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28
-
Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28
Secondary outcomes
-
Safety: Incidence of adverse events
Time frame: approximately 2 months
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
A Study to Evaluate the Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir When Administered Together in Healthy Adult Volunteers
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Apr 30, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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