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

Spero Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: TBPM-PI-HBr

Study type

Interventional

Funder types

Industry

Identifiers

NCT04625855

SPR994-106

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.