A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults

Tuberculosis Clinical Trial

Official title: A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects

Clinical Trial Description

This study is a two-part, open-label drug-drug interaction study conducted in one study center in the United States. Two groups are planned, Group 1 and Group 2. Group 2 will be conducted based on the Group 1 results.

Group 1 will assess the induction potential of TBAJ-876 on the sensitive CYP3A4 substrate midazolam (M) and inhibition and induction potential of TBAJ-876 on the sensitive P-glycoprotein substrate Digoxin (D).

Group 2 will only be conducted if the results of Group 1 show that TBAJ-876 is a moderate inducer of either CYP3A4 (midazolam AUC <0.50 when co-administered with TBAJ-876) or P-glycoprotein (digoxin AUC <0.50 when co-administered with TBAJ-876) or a moderate inhibitor of P-glycoprotein (digoxin AUC ≥2.0 when co-administered with TBAJ-876.

This group will quantify the magnitude of inhibition or induction of TBAJ-876 on the antiretroviral regimen TLD, a fixed dose combination of tenofovir disoproxil fumarate (TFD), lamivudine (3TC) and dolutegravir (DTG), a regimen likely to be used in future clinical studies of TBAJ-876 by subjects living with HIV.

Safety will be assessed throughout the study for all subjects. Safety assessments will include physical examinations, vital signs, serial ECGs, adverse events (AEs), clinical and laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis). ;

Related Conditions & MeSH terms

• Drug Sensitive Tuberculosis
• Drug-resistant Tuberculosis
• Latent Tuberculosis
• Multi Drug Resistant Tuberculosis
• Mycobacterium Tuberculosis Infection
• Pulmonary Disease
• Tuberculosis
• Tuberculosis, Multidrug-Resistant
• Tuberculosis, Pulmonary

• NCT number: NCT05526911
• Study type: Interventional
• Source: Global Alliance for TB Drug Development
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2022
• Completion date: August 28, 2022