Trials / Completed
CompletedNCT04178577
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function
A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees of Renal Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Spero Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally. |
Timeline
- Start date
- 2019-12-06
- Primary completion
- 2020-09-06
- Completion
- 2020-09-11
- First posted
- 2019-11-26
- Last updated
- 2020-11-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04178577. Inclusion in this directory is not an endorsement.