Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT04238195
Brief 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.
Study:
NCT04238195
Study Brief:
Protocol Section:
NCT04238195