Status:
COMPLETED
TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer
Lead Sponsor:
Tibotec BVBA
Conditions:
Tuberculosis
HIV
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 volunte...
Detailed Description
TMC207 is being investigated for the treatment of MDR-TB infection. This is a Phase I, open-label, randomized crossover trial in healthy volunteers to investigate the potential interaction between ste...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00828529
Start Date
February 1 2009
End Date
May 1 2009
Last Update
August 15 2012
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