NCT04238195

A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide \[TBPM-PI-HBr\]/placebo only), placebo- and active-control, single-dose, 4-way crossover study that will enroll 24 healthy adult male and female subjects. There will be a washout period of at least 7 days between dosing in each period and each subject will receive all 4 treatments over 4 periods in a crossover study design.

Detailed description

This is a randomized, double-blind (with respect to TBPM-PI-HBr / placebo only), placebo- and active-control, single-dose, 4-way crossover study. Twenty-four (24) healthy, adult, male and female subjects will be enrolled. Screening of subjects will occur within 28 days prior to the first dosing. All subjects will receive a single dose of 4 different study treatments over 4 separate treatment periods, each separated by a 7-day washout period. On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Sentinel group: In Period 1 only, 4 subjects will be dosed 24 hours prior to the remaining 20 subjects. Each of the 4 subjects from the sentinel group will receive a different treatment. On Day 1 of each period, subjects will receive a single oral therapeutic dose of TBPM-PI-HBr (Treatment A), supratherapeutic dose of TBPM-PI-HBr (Treatment B), placebo (Treatment C), or moxifloxacin (Treatment D) according to the randomization scheme. In each period, cardiodynamic ECGs and PK blood samples will be collected pre-dose and for 24 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations. Discontinued subjects who have received study drug will not be replaced.

Conditions

• TQT Study

Interventions

Type	Name	Description
DRUG	Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo	Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo.
DRUG	Moxifloxacin 400mg	Treatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner.
OTHER	Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)	Treatment C: Subjects receive TBPM-PI-HBr matching placebo.
DRUG	Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)	Treatment B: Subjects receive TBPM-PI-HBr.

Timeline

• Start date: 2020-01-19
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2020-01-23
• Last updated: 2020-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study