Healthy Volunteers
Conditions
Keywords
pharmacokinetics, TBPM-PI-HBr, tebipenem, absorption, metabolism, excretion
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.
Interventions
DRUGTBPM-PI-HBr
TBPM-PI-HBr (3 x 200 mg tablets) once
Sponsors
Covance
Spero Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open-Label)
Intervention model description
Single-Center, Open-Label, Non-Randomized, Phase 1 Study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects | Day 1 to Day 5 | 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 |
| Total radioactivity will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects | Day 1 to Day 5 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 secondary metabolite outcome endpoints will be derived: * metabolic profile of TBPM-PI-HBr * metabolic profile of TBPM-PI-HBr |
| 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 secondary safety outcome measures for this study are as follows: • incidence and severity of AEs |
Countries
United States
Outcome results
None listed