TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives are to determine the effect of different ritonavir doses on darunavir (DRV) oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and tolerability.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening

Exclusion Criteria:

• A positive HIV-1 or HIV-2 test at screening

• Hepatitis A, B, or C infection (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen [with a positive hep B PCR], or hepatitis C virus antibody, respectively) at Screening

• Any history of significant skin disease such as, but not limited to, rash or eruptions, food or drug allergy, dermatitis, eczema, psoriasis, folliculitis, or urticaria

• Use of concomitant medication, including over-the-counter products, herbal preparations and dietary supplements. Concomitant medication must have been discontinued at least 14 days before the first dose of trial medication except for paracetamol (acetaminophen), hormone replacement therapy and hormonal contraceptives

• Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.