NCT03758612

A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults

A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) With a Food Effect Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adult Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.

Detailed description

This study was a partially-blinded, placebo-controlled, randomized SAD study conducted at one study center. The primary objective of the study was to evaluate the safety and tolerability of single doses of TBI-223 oral suspension, TBI-223 oral enteric capsules, and TBI-223 tablet formulations in healthy adult subjects. The secondary objectives of the study were to determine the PK of TBI-223 and its metabolite M2 after single doses of TBI-223 oral suspension, TBI-223 oral enteric capsules, and TBI-223 tablet formulations in healthy adult subjects, and to compare the rate and extent of absorption of a single dose of TBI-223 oral suspension and TBI-223 tablet formulations when administered in healthy adult subjects either after a high-calorie, high-fat meal or in the fasting state. Safety was assessed throughout the study for all subjects. Safety assessments included physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).

Conditions

• Tuberculosis
• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	TBI-223 oral suspension	TBI-223 oral suspension, orally administered.
DRUG	TBI-223 enteric capsule	TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
DRUG	TBI-223 SR Tablet Prototype 1	TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
DRUG	TBI-223 SR Tablet Prototype 2	TBI-223 600 mg SR tablet Prototype 2, orally administered.
DRUG	TBI-223 SR Tablet Prototype 3	TBI-223 900 mg SR tablet Prototype 3, orally administered.
DRUG	TBI-223 IR Tablet	TBI-223 1000 mg immediate release (IR) tablet, orally administered
DRUG	Placebo suspension	Placebo for TBI-223 oral Suspension; orally administered.

Timeline

• Start date: 2019-01-16
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2018-11-29
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study