Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the pharmacokinetic interaction between etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in healthy Human Immunodeficiency Virus- (HIV-)negative patients. 'Pharmacokinetic interaction' means that one medication can influence the absorption and elimination from the body of the other medication.

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Darunavir; Etravirine; Lumefantrine; Ritonavir

Criteria

Inclusion Criteria:

• if of childbearing potential or if male, use a highly effective method of birth control.

• Able to comply with protocol requirements.

• A BMI (weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included.

• healthy on the basis of a medical evaluation

• Non-smoking for at least 3 months prior to selection.

Exclusion Criteria:

• previously demonstrated clinically significant allergy, hypersensitivity or intolerance to any of the investigational medications or its excipients

• Use of concomitant medication, including over-the-counter products and dietary supplements.

• Having participated in more than 1 study (single or multiple dose) with ETR (TMC125), DRV (TMC114), dapivirine (TMC120) and/or rilpivirine (TMC278, formerly known as R278474), or having developed a rash, erythema or urticaria while participating in a study with the aforementioned compounds.

• A positive pregnancy test or breast feeding at screening or on Day 1.

• Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements