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

NCT04625855 | Completed Phase 1 FDA Drug

• 1 other identifier: SPR994-106
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

pharmacokinetics; TBPM-PI-HBr; tebipenem; absorption; metabolism; excretion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• 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

  Day 1 to Day 5

• 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

  Day 1 to Day 5

• The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.

  Day 1 to Day 5

• The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.

  Day 1 to Day 5

Study Arms (1)

TBPM-PI-HBr

EXPERIMENTAL

Healthy subjects meeting eligibility criteria will receive a single dose of 600mg of TBPM-PI-HBr

Drug: TBPM-PI-HBr

Interventions

TBPM-PI-HBr DRUG

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

Also known as: TBPM-PI-HBr oral capsule

TBPM-PI-HBr

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy adult males, of any race
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spero Therapeutics: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Irene Mirkin, MD

  Covance Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open-Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-Center, Open-Label, Non-Randomized, Phase 1 Study

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: November 12, 2020
• Study Start: September 30, 2020
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)