TBAJ-587-CL-001, Phase 1, Partially Blinded, Placebo-Controlled, Randomized, Combined Single Ascending Dose with Food Effect Cohort Trial (Part 1) and Multiple Ascending Dose Trial (Part 2) to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-587 in Healthy Adult Participants.

TBAJ-587-CL-001, Phase 1, Partially Blinded, Placebo-Controlled, Randomized, Combined Single Ascending Dose with Food Effect Cohort Trial (Part 1) and Multiple Ascending Dose Trial (Part 2) to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-587 in Healthy Adult Participants. - CS0345-190557 TB Alliance

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54986

Enrollment

133

Registered

2020-07-14

Start date

2020-12-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

The test product is TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation and TBAJ-587 matching placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Provide written, informed consent prior to all trial-related procedures. Healthy adult male and females of non-childbearing potential, 18-64 years of age (inclusive) at the time of screening. Body mass index (BMI) >= 18.5 and

Exclusion criteria

Exclusion criteria: History or presence of significant cardiovascular abnormalities, Heart Murmur, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as determined by the Investigator to be clinically relevant. Any musculoskeletal toxicity (severe tenderness with marked impairment of activity) or musculoskeletal toxicity (frank necrosis). History of any illness that, in the opinion of the Investigator, might confound the results of the trial or poses an additional risk to the participant by their participation in the trial. Surgery within the past 90 days prior to dosing or other previous surgery as determined by the Investigator to be clinically relevant.

Design outcomes

Primary

Measure	Time frame
PK Part 1: Single Ascending Dose Noncompartmental PK parameters of AUClast, AUCinf, Cmax, tmax, CL/F, Vz/F, z, and t1/2 will be calculated from plasma concentrations of TBAJ-587, M2, M3 and M12. Additional PK parameters may be calculated if deemed appropriate. All clinical safety data will be listed by participant. Continuous variables will be summarized using sample size (N), mean, standard deviation, median, minimum, and maximum. Part 2: Multiple Ascending Dose Multiple ascending dose cohort PK parameters using noncompartmental analysis, calculated from plasma concentrations of TBAJ-587, M2, M3 and M12 following doses on Days 1, 14 and 28, will include: Day 1: AUCtau, Cmax, Tmax. Clast, Tmax. Parameters such as CL/F, Vz/F, z, and t1/2 which require extrapolations of the concentration profile to infinity, may be calculated of PK results from the SAD indicate the feasibility based on 24 hours of sampling; otherwise not. If so, if for any individual participant AUCtau	—

Measure

Time frame

PK Part 1: Single Ascending Dose Noncompartmental PK parameters of AUClast, AUCinf, Cmax, tmax, CL/F, Vz/F, *z, and t1/2 will be calculated from plasma concentrations of TBAJ-587, M2, M3 and M12. Additional PK parameters may be calculated if deemed appropriate. All clinical safety data will be listed by participant. Continuous variables will be summarized using sample size (N), mean, standard deviation, median, minimum, and maximum. Part 2: Multiple Ascending Dose Multiple ascending dose cohort PK parameters using noncompartmental analysis, calculated from plasma concentrations of TBAJ-587, M2, M3 and M12 following doses on Days 1, 14 and 28, will include: Day 1: AUCtau, Cmax, Tmax. Clast, Tmax. Parameters such as CL/F, Vz/F, *z, and t1/2 which require extrapolations of the concentration profile to infinity, may be calculated of PK results from the SAD indicate the feasibility based on 24 hours of sampling; otherwise not. If so, if for any individual participant AUCtau

—

Secondary

Measure	Time frame
Nap.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)