TASK 011-RPT-Crush:Relative bioavailability of three generic rifapentine and isoniazid compounds when manipulated in adults with latent tuberculosis: a bridge to paediatric dosing needs (RPT CRUSH”)
- Conditions
- Tuberculosis
- Registration Number
- PACTR202306775627089
- Lead Sponsor
- Stellenbosch University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
1.Written informed consent
2.Able/willing to comply with the protocol requirements
3.Aged between 18 and 65 years
4.Documented recent TB exposure
5.Evidence of TB infection (positive IGRA or TST <3 months prior to enrolment)
6.Body weight =40kg and = 90 kg
7.If of child-bearing potential, agree to use effective birth-control measures throughout the study.
1.Diseases or conditions in which use of RPT/INH contraindicated;
2.Known hypersensitivity or intolerance to RPT or INH;
3.Recent TB exposure to drug-resistant TB
4.Confirmed or suspected active TB
5.HIV infection;
6.Active chronic hepatitis B (HBsAg positive)
7.Females who are pregnant, breastfeeding, or planning to conceive a child within the study period
8.Laboratory abnormalities at screening; including anemia, leukopenia, thrombopenia, renal failure or hepatitis.
9.Use of any prohibited medication
10.Current participation in any other intervention trial of a therapeutic agent
11.Screening drug test positive for amphetamines/methamphetamines, opioids, methaqualone, benzodiazepines
12.Self-reported alcohol use exceeding 28 units per week for men, or 21 units for women
13.Clinically significant diseases/abnormalities that might compromise safety of the participant/interpretability of data.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To estimate the relative bioavailability of Rifapentine (RPT) and Isoniazid (INH) following dosing with 1) RPT/INH FDC (MacLeods), 2) RPT/INH FDC (Lupin) or 3) RPT single compound (Lupin) given with INH single compound (Winthrop/MacLeods), administered suspended in water compared to dosing as whole tablets
- Secondary Outcome Measures
Name Time Method 1. To investigate potential differences in absorption rate and variability of RPT and INH following dosing as whole tablets versus suspended in water<br>;2. To describe other derived pharmacokinetic (PK) parameters including Cmax, Tmax and area under the concentration-time curve (AUC)0-168hr for RPT and 25-Desacetyl-Rifapentine metabolite;3. To describe other derived pharmacokinetic parameters including Cmax, Tmax and AUC0-24hr INH;4. To describe the short-term safety of suspended RPT/INH;5. To describe the palatability and acceptability of suspended RPT/INH;6. To estimate the relative bioavailability of RPT and INH following dosing with RPT/INH FDC (MacLeods) or RPT/INH FDC (Lupin) compared to RPT single compound (Lupin) given with INH single compound (Winthrop/MacLeods), respectively, administered as whole tablets