Healthy VolunteersPhase 1NCT04625855
Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
A Phase 1 study testing TBPM-PI-HBr in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TBPM-PI-HBr
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 16 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704
About this study
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
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
- Being tested
- TBPM-PI-HBr
- Keywords
- pharmacokinetics, TBPM-PI-HBr, tebipenem, absorption, metabolism, excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBPM-PI-HBrDrug
Also called TBPM-PI-HBr oral capsule
TBPM-PI-HBr (3 x 200 mg tablets) once
| Study group | Role | What they receive |
|---|---|---|
| TBPM-PI-HBr | Experimental | Healthy subjects meeting eligibility criteria will receive a single dose of 600mg of TBPM-PI-HBr Receives: Drug: TBPM-PI-HBr |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 5
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
Measured: Day 1 to Day 5
Secondary outcomes (4)
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
Measured: Day 1 to Day 5
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
Measured: Day 1 to Day 5
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
Measured: Day 1 to Day 5
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
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start30 Sep 2020
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Center, Open-Label, Non-Randomized, Phase 1 Study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Irene Mirkin, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625855
- Sponsor's protocol ID
- SPR994-106
- Status last verified
- Nov 2020
- First submitted
- 17 Sep 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04625855
- Acronym / sponsor ID
- SPR994-106
- Conditions
- Healthy Volunteers
- Keywords
- pharmacokinetics, TBPM-PI-HBr, tebipenem, absorption, metabolism, excretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spero TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Center, Open-Label, Non-Randomized, Phase 1 Study
| Arm | Type | Receives |
|---|---|---|
| TBPM-PI-HBr | Experimental | Drug: TBPM-PI-HBrHealthy subjects meeting eligibility criteria will receive a single dose of 600mg of TBPM-PI-HBr |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBPM-PI-HBrAlso: TBPM-PI-HBr oral capsuleTBPM-PI-HBr (3 x 200 mg tablets) once | Drug | TBPM-PI-HBr |
Primary outcome
Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects
Time frame: 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
Time frame: 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
4 secondary outcomes
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
Time frame: Day 1 to Day 5
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
Time frame: Day 1 to Day 5
The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.
Time frame: Day 1 to Day 5
The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.
Time frame: Day 1 to Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Mirkin, MD principal investigator
Covance Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBPM-PI-HBr in people with Healthy Volunteers, run by Spero Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects (time frame: Day 1 to Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.