Status:
COMPLETED
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
Lead Sponsor:
Global Alliance for TB Drug Development
Conditions:
Tuberculosis
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects will receive a sin...
Eligibility Criteria
Inclusion
- Aged between 19 and 55 years, extremes included.
- Non tobacco/nicotine using (at least 3 months prior to screening).
- Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, inclusive.
- Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
- Able to comply with protocol requirements.
- Healthy on the basis of a medical evaluation or history 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, and hematology tests and a urinalysis carried out at screening (See Section 6.1).
Exclusion
- Female, except if postmenopausal since more than 2 years, or post-hysterectomy, or post surgical sterilization, i.e., tubal ligation (without reversal operation) or total hysterectomy.
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures.
- Any clinically significant (as deemed by the Principle Investigator) history acute illness (resolved within 4 weeks of screening), or presence of cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including eating disorders), endocrine, metabolic, immunologic, dermatologic, neurologic, psychological, or psychiatric disease.
- Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
- Any history of significant skin disease such as, but not limited to, rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria. Subjects with a history of skin disease may be enrolled into the study after consultation with the Sponsor Medical Monitor.
- Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial (i.e. rifapentine, rifampicin, and TMC207).
- Subjects with QTcF \[Fredericia correction\] interval \> 450 msec (based on the average of the triplicate ECGs) at screening (and confirmed by repeat ECG).
- Subjects with any other clinically significant ECG abnormality at screening, such as arrhythmia, ischemia, or evidence of heart failure or with a family history of Long QT Syndrome.
- Use of concomitant medication, including over-the-counter products and dietary supplements, except for ibuprofen and paracetamol up to 7 days before the first dose of trial medication and all prescribed medication must have been discontinued at least 14 days before first intake of trial medication.
- Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
- Donation of blood or significant loss of blood within 56 days or plasma donation within 7 days preceding the first intake of trial medication.
- Having received TMC207 in a previous trial.
- 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, or hepatitis C virus antibody, respectively) at screening.
- A positive urine drug test at screening. Urine will be tested to check the current use of alcohol, amphetamines, benzodiazepines, cocaine, cannabinoids, and opioids.
- Subjects with the following laboratory abnormalities at screening as defined by the NIH, NIAID, Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table and in accordance with the normal ranges of the clinical laboratory: Serum creatinine grade 1 or greater (\> 1.0 x ULN); Pancreatic lipase grade 1 or greater (\> 1.0 x ULN); Hemoglobin grade 1 or greater (≤ 10.5 g/dL); Platelet count grade 1 or greater (≤ 99000/mm3); Absolute neutrophil count grade 1 or greater (≤ 1500/mm3); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (\> 1.0 x ULN); Total bilirubin grade 1 or greater (\> 1.0 x ULN); Any other toxicity grade 2 or above, including: proteinuria (spot urine) \> 1+ and gross hematuria.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02216331
Start Date
March 1 2010
End Date
May 1 2010
Last Update
September 6 2019
Active Locations (1)
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1
Celerion (MDS Pharma Services)
Lincoln, Nebraska, United States, 68502