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

NCT ID: NCT04625855

Last Updated: 2020-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2020-10-16

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

Study Design

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

Study Groups

TBPM-PI-HBr

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

Group Type: EXPERIMENTAL

TBPM-PI-HBr

Intervention Type: DRUG

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

Interventions

TBPM-PI-HBr

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

Intervention Type: DRUG

Other Intervention Names

TBPM-PI-HBr oral capsule

Eligibility Criteria

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.

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

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Spero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Mirkin, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit

Locations

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

SPR994-106

Identifier Type: -

Identifier Source: org_study_id