A Study to Compare Two Bioanalytical Assays for Tebipenem

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05856747
• Other study ID #: SPR994-109
• Status: Completed
• Phase: Phase 1
• Start date: May 4, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Spero Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TBP-PI-HBr
TBP-PI-HBr tablets.

Locations

Country	Name	City	State
United States	BioPharma Services	Creve Coeur	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Spero Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Pre dose and at multiple time points post dose on Day 1
Primary	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-8) of TBP		Pre dose and at multiple time points post dose on Day 1
Primary	Maximum Plasma Concentration (Cmax) of TBP		Pre dose and at multiple time points post dose on Day 1
Secondary	Number of Participants With Adverse Events (AEs)		From first dose of study drug up to Day 6