Clinical trial NCT04625855: Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetics
TBPM-PI-HBr
tebipenem
absorption
metabolism
excretion
Lead sponsor: Spero Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2020-11-12
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Center, Open-Label, Non-Randomized, Phase 1 Study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects
timeFrame: Day 1 to Day 5
measure: Total radioactivity will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects
timeFrame: Day 1 to Day 5
Secondary outcomes:
measure: 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
timeFrame: Day 1 to Day 5
measure: 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
timeFrame: Day 1 to Day 5
measure: The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.
timeFrame: Day 1 to Day 5
measure: The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.
timeFrame: Day 1 to Day 5
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
affiliation: Covance Clinical Research Unit
name: Irene Mirkin, MD
role: PRINCIPAL_INVESTIGATOR
References: