Trials / Completed
CompletedNCT04625855
Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Spero Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TBPM-PI-HBr | TBPM-PI-HBr (3 x 200 mg tablets) once |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2020-10-16
- Completion
- 2020-10-16
- First posted
- 2020-11-12
- Last updated
- 2020-11-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04625855. Inclusion in this directory is not an endorsement.