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

NCT05526911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-10-08

Study results available
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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

Conditions

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

Interventions

DRUG

TBAJ-876

* Day 6 to Day 13: 200 mg TBAJ-876 oral suspension, fed * Day 14 to Day 19: 165 mg TBAJ-876 oral suspension, fed * Day 20 and Day 21: 200 mg TBAJ-876 oral suspension, fasting * Day 22 to Day 24: 150 mg TBAJ-876 oral suspension, fed

DRUG

Midazolam

Day 1 and Day 20: Midazolam oral syrup: 2 mg, fasted

DRUG

Digoxin

Day 2 and Day 21: Digoxin tablet: 0.25 mg, fasted

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Antonio Lombardi, MD · Global Alliance for TB Drug Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-09-26
Completion
2022-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526911 on ClinicalTrials.gov