Skip to main content
OpenTrials
Completed

NCT Number: NCT06727136

A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants

The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Facility, Salt Lake City

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
  • Body weight considering body mass index (BMI) within the range of 18 to 32 kilogram per meter square (kg/m^2), inclusive.
  • Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 55 years of age inclusive, at the time of signing the informed consent.

Exclusion criteria

  • History or presence of/significant history of or current cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or study procedures or interfering with the interpretation of data.
  • Past or intended use of over-the-counter or prescription medication including herbal medications within 28 days prior to dosing, with the exception of supplemental vitamins, hormonal medications (contraceptives or hormone-replacement therapy), or occasional oral acetaminophen (not to exceeding 2 g total daily dose).
  • Current enrollment or past participation in another investigational/observational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days, or 5 half-lives whichever is longer.
  • Positive COVID-19 screening test using PCR or antigen assay at Day -1
  • Donation of, or significant blood loss of, more than 500 mL of blood within 56 days prior to dosing.
  • Receipt of a blood transfusion within 1 year prior to enrollment or plasma donation within 7 days prior to dosing.
  • QTc >450 msec.

Note: Other inclusion/exclusion criteria may also apply

Treatment and study plan

TBP-PI-HBr

Drug

TBP-PI-HBr film-coated immediate-release tablets

Other names: SPR994

Primary outcomes

  1. Part A and B: Maximum Observed Concentration (Cmax) of TBP in Plasma and Blood

    Time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  2. Part A and B: Time to Cmax (Tmax) of TBP in Plasma and Blood

    Time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  3. Part A and B: Area Under the Concentration-Time Curve (AUC) Extrapolated to Infinity [AUC(0-inf)] of TBP in Plasma and Blood

    Time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  4. Part A and B: AUC From Time Zero to the Time of the Last Evaluable Concentration [AUC(0-t)] of TBP in Plasma and Blood

    Time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  5. Part A and B: Amount Excreted in Urine (Ae) of TBP

    Time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  6. Part A and B: Fraction of Dose Excreted in Urine (Fe) of TBP

    Time frame: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7

  7. Part B: AUC From Time Zero to 6 Hours Post-dose AUC(0-6) of TBP in Plasma and Blood

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  8. Part B: Ae of SPR1349

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  9. Part B: Fe of SPR1349

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

Secondary outcomes

  1. Part B: Tmax of SPR1349 in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  2. Part B: Cmax of SPR1349 in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  3. Part B: AUC(0-inf) of SPR1349 in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  4. Part B: AUC(0-t) of SPR1349 in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  5. Part B: AUC(0-6) of SPR1349 in Plasma

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  6. Part B: Plasma AUC Ratio of SPR1349 to TBP

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  7. Part B: Ae Ratio of SPR1349 to TBP

    Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7

  8. Parts A and B: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 to Day 21

Sponsors and collaborators

Lead sponsor

Spero Therapeutics

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Phase 1, Open-label Study to Characterize Single and Repeat Dose Pharmacokinetics (Including Food Effect) of Tebipenem-pivoxil-hydrobromide and Its Major Metabolite (SPR1349) in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.