A Phase I, open-label, randomized, 3-panel, 3-way crossover trial in healthy adult subjects to assess the relative bioavailability of TMC435 following administration of 2 liquid formulations or 2 different capsule concept formulations compared to the Phase III 150 mg capsule, and to assess the effect of food on the bioavailability of TMC435 following administration of the liquid formulations.

Janssen R&D Ireland0 个研究点开始时间: 2012年3月1日最近更新: 2012年8月28日

适应症

试验速览

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•- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead electrocardiogram and vital signs, performed at screening, have a body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to screening.
•- Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 72
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
•- Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen. - Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant or prevent the subject from meeting or performing study requirements.
•- History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
•- Participation in an investigational drug trial with TMC435.
•- Infected with HIV or Hepatitic A, B or C.

发起方

Janssen R&D Ireland