A Study to Compare Two Bioanalytical Assays for Tebipenem

NCT ID: NCT05856747

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2023-06-01

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TBP-PI-HBr 600 mg

Healthy participants meeting eligibility criteria will receive a single oral dose of TBP-PI-HBr 600 mg tablets (2 x 300 mg) on Day 1 under fasted conditions.

Group Type: EXPERIMENTAL

TBP-PI-HBr

Intervention Type: DRUG

TBP-PI-HBr tablets.

Interventions

TBP-PI-HBr

TBP-PI-HBr tablets.

Intervention Type: DRUG

Other Intervention Names

SPR994

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BioPharma Services

Creve Coeur, Missouri, United States

Countries

United States

Other Identifiers

SPR994-109

Identifier Type: -

Identifier Source: org_study_id