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Group 1 for Tuberculosis

Phase 1

Waitlist Available

Research Sponsored by Global Alliance for TB Drug Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours; day 21: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours

Awards & highlights

Study Summary

This trial will test the safety and tolerability of a new drug, TBAJ-876, and its potential to affect two other drugs, CYP3A4 and P-glycoprotein.

Eligible Conditions

Tuberculosis
Lung Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours; day 21: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours; day 21: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours; day 21: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TBAJ-876 effect on the pharmacokinetics of the CYP-3A4 substrate midazolam and the inhibition potential of TBAJ-876 on P-gp in healthy adult subjects

Digoxin

Secondary outcome measures

Number of Participants with Treatment-Related Adverse Events in Group 1 Population

Number of Participants with Treatment-Related Adverse Events in Group 2 Population

Trial Design

2Treatment groups

Active Control

Group I: Group 1Active Control3 Interventions

The pharmacokinetics of midazolam, a CYP3A4 substrate, and digoxin, a P-gp substrate, will be studied before and after dosing with TBAJ-876.

Group II: Group 2Active Control2 Interventions

The pharmacokinetics of antiretroviral regimen TLD will be studied before and after dosing with TBAJ-876.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Global Alliance for TB Drug DevelopmentLead Sponsor

37 Previous Clinical Trials

8,373 Total Patients Enrolled

37 Trials studying Tuberculosis

8,373 Patients Enrolled for Tuberculosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated participant count for this clinical trial?

"Yes, the information online confirms that this investigation is still recruiting. This research was first posted on July 21st 2022 and last updated at the end of August 2022 with a goal to enlist 44 patients from 1 site."

Answered by AI

Could participants under the age of twenty be included in this research?

"The minimum age of admittance to this trial is 18, while the highest permissible age limit is 55."

Answered by AI

What qualifications must an individual meet in order to be eligible for this clinical experiment?

"This clinical trial is recruiting 44 individuals aged 18-55 who are suffering from pulmonary tuberculosis. Other criteria for enrolment include being a healthy male or female, having no nicotine product use in the past 6 months and meeting body mass index (BMI) requirements of between 18.5 to 32 kg/m2 with minimum weight of 50kg. Additionally, all patients must be comfortable consuming high calorie meals within specified timeframe."

Answered by AI

Does Group 1 meet the regulatory standards of the FDA?

"Our team's assessment of Group 1's safety is a score of 1, as this trial is only in Phase 1 and thus has limited data backing the drug’s efficacy or safety."

Answered by AI

Are any openings still available for participants in this clinical trial?

"Clinicaltrials.gov confirms that this experiment is still recruiting patients, having originally been posted on July 21st 2022 and most recently updated on August 31st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526911.