Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: TBPM-PI-HBr

• Registration Number: NCT04625855
• Lead Sponsor: Spero Therapeutics

Brief Summary

The purpose of this study is to determine the absorption, metabolism, and excretion of \[14C\]-TBPM-PI-HBr and to characterize and determine the metabolites present in plasma, urine, and where possible, feces in healthy male subjects following a single oral administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study Start: 2020-09-30
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TBPM-PI-HBr	TBPM-PI-HBr	Healthy subjects meeting eligibility criteria will receive a single dose of 600mg of TBPM-PI-HBr

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects	Day 1 to Day 5	The primary PK outcome endpoints following oral administration of \[14C\]-TBPM-PI-HBr will be derived for TBPM in plasma (calculated from whole blood concentrations) based on the concentration-time profile
Total radioactivity will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects	Day 1 to Day 5	The primary PK outcome endpoints following oral administration of \[14C\]-TBPM-PI-HBr will be derived for total radioactivity in whole blood and plasma based on the total radioactivity concentration-time profile

Secondary Outcome Measures

Name	Time	Method
Metabolite profiling and chemical structuring of metabolites in plasma, urine, and, where possible, feces will be determined after a single oral dose of [14C]-TBPM-PI-HBr	Day 1 to Day 5	The secondary metabolite outcome endpoints will be derived: • identification of the structure of TBPM-PI-HBr metabolites
The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.	Day 1 to Day 5	The secondary safety outcome measures for this study are as follows: •incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc.; 🇺🇸 Madison, Wisconsin, United States