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OpenTrials
Completed

NCT Number: NCT05856747

A Study to Compare Two Bioanalytical Assays for Tebipenem

The primary purpose of the study is to compare the concentrations of tebipenem (TBP), the active moiety of tebipenem pivoxil hydrobromide (TBP-PI-HBr), as determined by two bioanalytical assays, a whole blood assay and a plasma assay, following a single oral dose of TBP-PI-HBr 600 milligram (mg) tablets in healthy adult participants.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BioPharma Services

Creve Coeur, Missouri, 63141, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) at Screening visit.
  • Medically healthy with no clinically significant medical history, abnormalities in physical examination, laboratory variables, vital signs or electrocardiogram (ECG) at the time of Screening visit and Check-in (Day-1), as deemed by the investigator or designee.
  • Have suitable venous access for repeated blood sampling.

Exclusion criteria

  • Any clinically significant medical history or observations at the time of Screening visit or Check-in (Day -1) not specifically excluded in other criteria that, in the opinion of the investigator or designee, may confound the results of the study, compromise the safety of the participant or otherwise render the participant unsuitable for participation.
  • Use/receipt of any prescription or non-prescription medication, herbal products, vitamins or vaccines within 14 days (or 5 half-lives whichever is longer) prior to Check-in (Day -1).
  • Positive coronavirus disease (COVID-19) screening test using polymerase chain reaction (PCR) or antigen assay at Screening visit or Check-in (Day -1).
  • Donation or significant blood loss of more than 500 milliliter (mL) of blood within 56 days prior to enrollment, or receipt of a blood transfusion within 1 year prior to enrollment; plasma donation within 7 days prior to dosing.
  • ECG with corrected QT interval by Fridericia (QTcF) interval duration equal or greater than 450 milliseconds (msec) for males and 470 msec for females obtained after at least 5 minutes in a supine or semi-recumbent position at quiet rest at Screening visit or Check-in (Day -1).

Other inclusion and exclusion criteria as per protocol may apply.

Treatment and study plan

TBP-PI-HBr

Drug

TBP-PI-HBr tablets.

Other names: SPR994

Primary outcomes

  1. Percentage of Tebipenem (TBP) Samples With Converted (From Whole Blood Measurements) and Measured Plasma Concentrations That Have a Difference not Exceeding ±20% of the Mean of the Concentrations

    Time frame: Pre dose and at multiple time points post dose on Day 1

  2. Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-∞) of TBP

    Time frame: Pre dose and at multiple time points post dose on Day 1

  3. Maximum Plasma Concentration (Cmax) of TBP

    Time frame: Pre dose and at multiple time points post dose on Day 1

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: From first dose of study drug up to Day 6

Sponsors and collaborators

Lead sponsor

Spero Therapeutics

Industry

Registry information

Official study title

An Open-Label, Single-Center, Single-Period Study to Compare Two Bioanalytical Assays for Tebipenem Following Administration of Oral Tebipenem Pivoxil Hydrobromide in Healthy Adult Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 12, 2023
Registry last updated
Mar 27, 2024

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.

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