drugset
drugset / Trial / NCT07303699

ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)

NCT07303699 ↗

Phase 2 Recruiting 80 enrolled Obafemi Awolowo University Teaching Hospital Obafemi Awolowo University · collabOpen Philanthropy · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess pharmacokinetic parameters of atorvastatin at different doses when combined with the standard first line tuberculosis (TB) treatment regimen in adults with drug sensitive pulmonary TB. The pharmacokinetics parameters will be correlated with Pharmcodynamic measures and a PK/PD model that will identify an optimal dosing regimen of atorvastatin that is appropriate for the treatment of pulmonary tuberculosis will be developed.

Timeline

Start
2026-01-03
Primary completion
2027-03-30
Completion
2028-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg Oral
Subject Atorvastatin Small molecule 40 mg Oral
Subject Atorvastatin Small molecule 60 mg Oral
Background Ethambutol Small molecule — Oral
Background Isoniazid Small molecule — Oral
Background Pyrazinamid Unknown — Oral
Background Rifampin Small molecule — Oral

Indications

pulmonary tuberculosis