Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625855
• Other study ID #: SPR994-106
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2020
• Est. completion date: October 16, 2020

Study information

• Verified date: November 2020
• Source: Spero Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the absorption, metabolism, and excretion of [14C]-TBPM-PI-HBr and to characterize and determine the metabolites present in plasma, urine, and where possible, feces in healthy male subjects following a single oral administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• Healthy adult males, of any race, between 18 and 55 years of age, inclusive.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive at Screening.
• Willing and able to provide written informed consent and comply with all study assessments, restrictions, and adhere to the protocol schedule.
• Medically healthy with no clinically significant medical history, or abnormalities in physical examination, laboratory variables, vital signs or ECG at the time of screening and Check-in, as deemed by the Investigator (or designee).
• Have suitable venous access for repeated blood sampling.
• History of a minimum of 1 bowel movement per day. Exclusion Criteria
• History or suspicion of routine or chronic drug or alcohol abuse or dependence within 2 years prior to Check-in.
• Use of tobacco, nicotine, or nicotine-replacement products within 30 days prior to Check-in or planned use during the study.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Use/receipt of any prescription or nonprescription medication, herbal products, vitamins or vaccines within 14 days (or 5 half-lives whichever is longer) prior to Check-in, without prior approval from the Medical Monitor.
• Donation of more than 500 mL of blood or plasma within 56 days prior to Check-in, or receipt of a blood transfusion within 1 year prior to Check-in.
• Receipt of any other investigational product or participation in another investigational clinical study that included drug treatment within 30 days, or 5 times the t1/2 of the investigational drug, whichever is longer.
• Have previously completed or withdrawn from this study or any other study investigating TBPM-PI-HBr, and have previously received TBPM-PI-HBr.
• Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
• Subjects who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 3 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 3 other previous radiolabeled studies within 3 to 12 months prior to this study will be within the CFR recommended levels considered safe, per United States (US) Title 21 CFR 361.1.
• Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TBPM-PI-HBr
TBPM-PI-HBr (3 x 200 mg tablets) once

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Spero Therapeutics	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects	The primary PK outcome endpoints following oral administration of [14C]-TBPM-PI-HBr will be derived for TBPM in plasma (calculated from whole blood concentrations) based on the concentration-time profile	Day 1 to Day 5
Primary	Total radioactivity will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects	The primary PK outcome endpoints following oral administration of [14C]-TBPM-PI-HBr will be derived for total radioactivity in whole blood and plasma based on the total radioactivity concentration-time profile	Day 1 to Day 5
Secondary	Metabolite profiling and chemical structuring of metabolites in plasma, urine, and, where possible, feces will be determined after a single oral dose of [14C]-TBPM-PI-HBr	The secondary metabolite outcome endpoints will be derived: metabolic profile of TBPM-PI-HBr; metabolic profile of TBPM-PI-HBr	Day 1 to Day 5
Secondary	Metabolite profiling and chemical structuring of metabolites in plasma, urine, and, where possible, feces will be determined after a single oral dose of [14C]-TBPM-PI-HBr	The secondary metabolite outcome endpoints will be derived: • identification of the structure of TBPM-PI-HBr metabolites	Day 1 to Day 5
Secondary	The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.	The secondary safety outcome measures for this study are as follows: • incidence and severity of AEs	Day 1 to Day 5
Secondary	The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.	The secondary safety outcome measures for this study are as follows: •incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results	Day 1 to Day 5