Relative BioavailabilityPhase 1NCT05296382
Bioavailability of Tebipenem (SPR994) Crushed Tablet
A Phase 1 study testing Tebipenem tablet form and Tube feeds in people with Relative Bioavailability, run by Hartford Hospital at 1 site in United States.
Trial summary
The purpose of this study is to measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube with and without tube feeds. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Relative Bioavailability
- What is being tested?
- Tebipenem tablet form and Tube feeds
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 23 Dec 2022
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the trial, give written informed consent, and comply with the trial restrictions.
- Gender: male or female with a negative serum pregnancy test (β-human chorionic gonadotropin) at Screening and Day -1; females may be of childbearing potential or of non-childbearing potential.
- Age >= 18 years at screening
Who cannot join
- Female who is pregnant, lactating, or at risk of becoming pregnant during this trial.
- History of hypersensitivity or allergy to tebipenem or its derivatives and any β-lactam antibiotic.
- History of hypersensitivity to lidocaine or lidocaine derivatives.
- Concurrently receiving sodium valproic acid or valproate derivatives.
- Concurrently receiving probenecid.
- Body Mass Index (BMI) ≥ 35 kg/m2
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- Creatinine clearance (CrCl) < 50ml/min, as calculated by Cockcroft-Gault using ideal body weight
- Presence of anemia, thrombocytopenia, or leukopenia as defined by hematocrit, platelet, or white blood cell count < 75% of the lower limit of normal
- Aspartate transaminase, alanine aminotransferase, or alkaline phosphatase greater than five times upper limit of normal.
- Total bilirubin greater than three times the upper limit of normal.
- Any known active co-morbidity listed on medical history i.e., seizures or that becomes apparent during physical examination.
- Positive urine drug screen (cocaine, Tetrahydrocannabinol, opiates, benzodiazepines, and amphetamines).
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalence of 5 cigarettes per day.
- Consumption of caffeine within 3 days of the study.
- Use of prescription or nonprescription drugs, vitamins, or dietary supplements within 7 days or 5 half-lives, whichever is longer (with the exception of acetaminophen at doses of ≤ 1 g/day). The use of hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing intrauterine devices, post-coital contraceptive methods) is permitted.
- Males who are not surgically sterilized (with female partners of childbearing potential) and females of childbearing potential who do not agree to use two highly effective methods of contraception from screening, during this trial, and for 90 days after the last dose of study drug.
- History or current presence of nasal structural abnormalities including a broken nose or deviated septum.
- Employee of the Center for Anti-Infective Research and Development, Clinical Research Center, or the Sponsor.
- Any other documented reason felt by the investigator to potentially affect the outcomes of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of Tebipenem (SPR994) Crushed Tablet Formulation Administered by Nasogastric Tube in Healthy Subjects
The purpose of this study is to measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube with and without tube feeds.
Read the detailed description
This study will enroll 12 healthy volunteers and will take place in the Clinical Research Center at Hartford Hospital. Each volunteer will receive 2 doses (~22h washout period between doses) and will be randomly assigned to three treatment groups:
- intact tebipenem 600mg dose (2 300mg tablets) taken orally; 2) a crushed tebipenem 600mg dose (2 300mg tablets) suspended in water and administered via the NGT; 3) a crushed tebipenem 600mg dose (2 300mg tablets) suspended in water and administered via a nasogastric tube with concurrent enteral tube feeds (run for 2h before dose and 4h post-dose). Crushed tablets will be administered by syringe through the nasogastric tube. An additional 150ml of water will be used to rinse out any remaining drug in syringe and administered to the volunteers to ensure delivery of the entire dose.
- Conditions
- Relative Bioavailability
- Being tested
- Tebipenem tablet form, Tube feeds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tebipenem tablet formDrug
Tebipenem tablets will be administered intact or crushed
Tube feedsOther
Tebipenem tablets will be administered with or without tube feeds
| Study group | Role | What they receive |
|---|---|---|
| Crushed Tebipenem Tablet with Tube feeds | Experimental | Crushed tebipenem tablets will be administered by syringe through the nasogastric tube and flushed with water to ensure all drug is passed through. Subjects will also receive concurrent enteral tube feeds (feeds run for 2h before dose and 4h post-dose). Receives: Drug: Tebipenem tablet form; Other: Tube feeds |
| Whole Tebipenem Tablet | Experimental | Tebipenem tablet will be swallowed whole without crushing. Receives: Drug: Tebipenem tablet form |
| Crushed Tebipenem Tablet without Tube feeds | Experimental | Crushed tebipenem tablets will be administered by syringe through the nasogastric tube and flushed with water to ensure all drug is passed through. Receives: Drug: Tebipenem tablet form; Other: Tube feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tebipenem drug exposure
Tebipenem total and free blood concentrations following the tebipenem dose (intact)
Measured: 8 hours
Tebipenem drug exposure
Tebipenem total and free blood concentrations following the tebipenem dose (crushed and administered via NGT)
Measured: 8 hours
Tebipenem drug exposure
Tebipenem total and free blood concentrations following the tebipenem dose (crushed and administered with tube feeds via NGT)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative BioavailabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spero Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296382
- Sponsor's protocol ID
- HHC-2021-0354
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Tebipenem (SPR994) Crushed Tablet Formulation Administered by Nasogastric Tube in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05296382
- Acronym / sponsor ID
- HHC-2021-0354
- Conditions
- Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Spero Therapeutics
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 25 Mar 2022 (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 measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube with and without tube feeds.
Detailed description
This study will enroll 12 healthy volunteers and will take place in the Clinical Research Center at Hartford Hospital. Each volunteer will receive 2 doses (~22h washout period between doses) and will be randomly assigned to three treatment groups:
- intact tebipenem 600mg dose (2 300mg tablets) taken orally; 2) a crushed tebipenem 600mg dose (2 300mg tablets) suspended in water and administered via the NGT; 3) a crushed tebipenem 600mg dose (2 300mg tablets) suspended in water and administered via a nasogastric tube with concurrent enteral tube feeds (run for 2h before dose and 4h post-dose). Crushed tablets will be administered by syringe through the nasogastric tube. An additional 150ml of water will be used to rinse out any remaining drug in syringe and administered to the volunteers to ensure delivery of the entire dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crushed Tebipenem Tablet with Tube feeds | Experimental | Drug: Tebipenem tablet form, Other: Tube feedsCrushed tebipenem tablets will be administered by syringe through the nasogastric tube and flushed with water to ensure all drug is passed through. Subjects will also receive concurrent enteral tube feeds (feeds run for 2h before dose and 4h post-dose). |
| Whole Tebipenem Tablet | Experimental | Drug: Tebipenem tablet formTebipenem tablet will be swallowed whole without crushing. |
| Crushed Tebipenem Tablet without Tube feeds | Experimental | Drug: Tebipenem tablet form, Other: Tube feedsCrushed tebipenem tablets will be administered by syringe through the nasogastric tube and flushed with water to ensure all drug is passed through. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate in the trial, give written informed consent, and comply with the trial restrictions.
- Gender: male or female with a negative serum pregnancy test (β-human chorionic gonadotropin) at Screening and Day -1; females may be of childbearing potential or of non-childbearing potential.
- Age >= 18 years at screening
Key exclusion criteria (20 listed)
- Female who is pregnant, lactating, or at risk of becoming pregnant during this trial.
- History of hypersensitivity or allergy to tebipenem or its derivatives and any β-lactam antibiotic.
- History of hypersensitivity to lidocaine or lidocaine derivatives.
- Concurrently receiving sodium valproic acid or valproate derivatives.
- Concurrently receiving probenecid.
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 |
|---|---|---|
| Tebipenem tablet formTebipenem tablets will be administered intact or crushed | Drug | Crushed Tebipenem Tablet with Tube feeds, Crushed Tebipenem Tablet without Tube feeds, Whole Tebipenem Tablet |
| Tube feedsTebipenem tablets will be administered with or without tube feeds | Other | Crushed Tebipenem Tablet with Tube feeds, Crushed Tebipenem Tablet without Tube feeds |
Primary outcome
Tebipenem drug exposure
Time frame: 8 hours
Tebipenem total and free blood concentrations following the tebipenem dose (intact)
Tebipenem drug exposure
Time frame: 8 hours
Tebipenem total and free blood concentrations following the tebipenem dose (crushed and administered via NGT)
Tebipenem drug exposure
Time frame: 8 hours
Tebipenem total and free blood concentrations following the tebipenem dose (crushed and administered with tube feeds via NGT)
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 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tebipenem tablet form and Tube feeds in people with Relative Bioavailability, run by Hartford Hospital 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 3 inclusion and 20 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 28 Feb 2024. 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?
Tebipenem drug exposure (time frame: 8 hours). The study lists 3 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 28 Feb 2024.