Healthy Volunteers Clinical Trial
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
Verified date | November 2020 |
Source | Spero Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | October 16, 2020 |
Est. primary completion date | October 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Covance Clinical Research Unit, Inc. | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Spero Therapeutics | Covance |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | The secondary metabolite outcome endpoints will be derived: metabolic profile of TBPM-PI-HBr metabolic profile of TBPM-PI-HBr |
Day 1 to Day 5 | |
Secondary | 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 | The secondary metabolite outcome endpoints will be derived: • identification of the structure of TBPM-PI-HBr metabolites |
Day 1 to Day 5 | |
Secondary | The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects. | The secondary safety outcome measures for this study are as follows: • incidence and severity of AEs |
Day 1 to Day 5 | |
Secondary | The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects. | The secondary safety outcome measures for this study are as follows: •incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results |
Day 1 to Day 5 |
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