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Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function

NCT04178577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-11-27

No results posted yet for this study

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

  • Renal Impairment

Interventions

DRUG

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)

Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.

Sponsors & Collaborators

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Melnick, M.D. · Spero Therapeutics Inc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2020-09-06
Completion
2020-09-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178577 on ClinicalTrials.gov