Bioavailability of Tebipenem (SPR994) Crushed Tablet

NCT05296382 | Completed Phase 1 FDA Drug

• 1 other identifier: HHC-2021-0354
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relative Bioavailability

Outcome Measures

Primary Outcomes (3)

• Tebipenem drug exposure

  Tebipenem total and free blood concentrations following the tebipenem dose (intact)

  8 hours

• Tebipenem drug exposure

  Tebipenem total and free blood concentrations following the tebipenem dose (crushed and administered via NGT)

  8 hours

• Tebipenem drug exposure

  Tebipenem total and free blood concentrations following the tebipenem dose (crushed and administered with tube feeds via NGT)

  8 hours

Study Arms (3)

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).

Drug: Tebipenem tablet form; Other: Tube feeds

Whole Tebipenem Tablet

EXPERIMENTAL

Tebipenem tablet will be swallowed whole without crushing.

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.

Drug: Tebipenem tablet form; Other: Tube feeds

Interventions

Tebipenem tablet form DRUG

Tebipenem tablets will be administered intact or crushed

Crushed Tebipenem Tablet with Tube feeds; Crushed Tebipenem Tablet without Tube feeds; Whole Tebipenem Tablet

Tube feeds OTHER

Tebipenem tablets will be administered with or without tube feeds

Crushed Tebipenem Tablet with Tube feeds; Crushed Tebipenem Tablet without Tube feeds

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hartford Hospital: lead
• Spero Therapeutics: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 25, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 23, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)