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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 19, 2020

Primary Completion Date

February 26, 2020

Study Completion Date

February 26, 2020

Conditions

TQT Study

Interventions

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.

Trial Locations (1)

Celerion, Tempe