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Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers

NCT04710407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-16

No results posted yet for this study

Summary

To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TBPM-PI-HBr

TBPM-PI-HBr (2 x 300mg tablets) a total of five doses

Sponsors & Collaborators

  • Clinartis

    collaborator INDUSTRY

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Baratz, MD · Pulmonary Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2021-03-10
Completion
2021-03-10
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 NCT04710407 on ClinicalTrials.gov