Tuberculosis
Conditions
Interventions
Sponsors
Stellenbosch University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. To investigate potential differences in absorption rate and variability of RPT and INH following dosing as whole tablets versus suspended in water ;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 | — |
Countries
South Africa
Contacts
Public ContactCaryn Upton
Investigator
Outcome results
None listed