TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase I, open-label, randomized crossover trial is to investigate the pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207 in healthy volunteers.

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

Details

• Lead Sponsor: Tibotec BVBA
• Treatments: Bedaquiline; Diarylquinolines; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection

• Body Mass Index of 18.0 to 32.0 kg/m2, extremes included

• Able to comply with protocol requirements

• Healthy on the basis of a physical examination, medical history, ECG, vital signs and the results of blood biochemistry and hematology test and a urinalysis carried out at screening

• Informed Consent Form signed voluntarily before the first trial-related activity.

Exclusion Criteria:

• A positive HIV-1 or HIV-2 test

• Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post-surgical sterilization

• Hepatitis A, B, or C infection

• Evidence of current use of illicit drugs or opioids or abuse of alcohol

• Currently active or underlying disorders including gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease

• Any history of significant skin disease or allergy including allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial

• Use of concomitant medication, including over-the-counter products and dietary supplements, except for ibuprofen and paracetamol up to 3 days before the first dose of trial medication

• Recent donation of blood or plasma or participation in a clinical trial

• Subjects with QTc prolongation or any other clinically significant ECG abnormality or a family history of Long QT Syndrome.