NCT06593054

To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults

An Interventional Open-Label, Single-Dose, 4-Treatment, 4-Period Crossover Study to Evaluate the Relative Bioavailability of CTB and AVI Administered Via Various Tablets or Capsule Formulations of PF-07612577 (PF-06264006 [CTB] - PF-07338233 [AVP]) and the Effect of Food on the Bioavailability of CTB and AVI Administered Via Tablets in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn about the study medicine CTB-AVP for the treatment of severe urinary tract infections that require hospitalization. This study is seeking for: * adult male and female participants who are healthy and weigh more than 50 kg. * participants who have normal blood pressure, normal kidney and liver function * participants willing to stay away from caffeine and other medicines for the duration of the study. Participants will be required to stay in the study clinic for two weeks. All participants in this study will receive study medicine CTB-AVP by mouth one time each day on four different days. Study medicine will be given in capsules or tablets, on an empty stomach or will be taken with a meal. The study will look at the experiences of people receiving the study medicine. This will help determine if the study medicine is safe and effective.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ceftibuten	Ceftibuten dihydrate, formulated in capsules
DRUG	Avibactam prodrug	Avibactam prodrug, formulated in capsules
DRUG	CTB-AVP in Tablet	ceftibuten and avibactam prodrug, in Tablet formulation

Timeline

• Start date: 2024-07-29
• Primary completion: 2024-10-11
• Completion: 2024-10-11
• First posted: 2024-09-19
• Last updated: 2025-05-21

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study