NCT05296382

Bioavailability of Tebipenem (SPR994) Crushed Tablet

Relative Bioavailability of Tebipenem (SPR994) Crushed Tablet Formulation Administered by Nasogastric Tube in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

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: 1\) 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

Interventions

Type	Name	Description
DRUG	Tebipenem tablet form	Tebipenem tablets will be administered intact or crushed
OTHER	Tube feeds	Tebipenem tablets will be administered with or without tube feeds

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-06-01
• Completion: 2022-12-23
• First posted: 2022-03-25
• Last updated: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study