---
title: 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
nct_id: NCT06593054
overall_status: COMPLETED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06593054.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06593054"
ct_last_update_post_date: 2025-05-21
last_seen_at: "2026-05-12T07:06:58.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**Official Title:** 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

**NCT ID:** [NCT06593054](https://clinicaltrials.gov/study/NCT06593054)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 13
- **Lead Sponsor:** Pfizer
- **Conditions:** Healthy
- **Start Date:** 2024-07-29
- **Completion Date:** 2024-10-11
- **CT.gov Last Update:** 2025-05-21

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Male and female participants aged 18 years or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and standard 12-lead electrocardiogram (ECGs), and with eGFR ≥75 mL/min (estimated using the 2021 CKD-EPI equation).
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Have a body-mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease; including any condition affecting oral absorption or known allergy to cephalosporin group of antibiotics
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention or current use of any prohibited concomitant medications.
* Screening supine Blood Pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \<60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest
* Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: alanine aminotransferase (ALT), aspartate aminotransferase (AST), Bilirubin ≥1.5 x Upper Limit of Normal (ULN). Participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
```

## Arms

- **CTB-AVP Capsules, fasted** (EXPERIMENTAL) — Reference formulation of CTB-AVP in capsules, administered under fasted conditions
- **CTB-AVP Tablet , fasted** (EXPERIMENTAL) — Test formulation of CTB-AVP in tablets, administered under fasted conditions
- **CTB-AVP Tablet , fed** (EXPERIMENTAL) — Test formulation of CTB-AVP in tablets, administered under fed conditions

## Interventions

- **Ceftibuten** (DRUG) — Ceftibuten dihydrate, formulated in capsules
- **Avibactam prodrug** (DRUG) — Avibactam prodrug, formulated in capsules
- **CTB-AVP in Tablet** (DRUG) — ceftibuten and avibactam prodrug, in Tablet formulation

## Primary Outcomes

- **Maximum Observed Plasma Concentration [Cmax] of cis-CTB and AVI following test formulation administration in fasted or fed state** _(time frame: Through 48 hours in period 1, 2, 3)_ — Cmax is estimated based on the plasma concentrations for test and reference formulation
- **Dose-normalized Maximum Observed Plasma Concentration [Cmax(dn)] of cis-CTB and AVI following test/ reference formulation administration** _(time frame: Through 48 hours in period 1, 2, 3)_ — Cmax is estimated based on the plasma concentrations for test and reference formulation and then normalized by dose
- **Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of cis-CTB and AVI following test formulation administration in fasted or fed state** _(time frame: Through 48 hours in period 1, 2, 3)_ — Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- **Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast(dn)] of cis-CTB and AVI following test/ reference formulation administration** _(time frame: Through 48 hours in period 1, 2, 3)_ — Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) normalized by dose
- **Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of cis-CTB and AVI (if data permit) following test formulation administration in fasted or fed state** _(time frame: Through 48 hours in period 1, 2, 3)_ — AUC (inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUClast plus AUClast to infinity.
- **Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf(dn)] of cis-CTB and AVI (if data permit) following test/ reference formulation administration** _(time frame: Through 48 hours in period 1, 2, 3)_ — AUC (inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUClast plus AUClast to infinity normalized by dose

## Secondary Outcomes

- **Number of participants with Treatment Emergent Adverse Events (TEAE)** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Severity of treatment-emergent adverse events (TEAEs)** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Causal relationship of treatment-emergent adverse events (TEAEs)** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Withdrawals due to treatment-emergent adverse events (TEAEs)** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Number of Participants With Laboratory Abnormalities** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Number of Participants With Clinically Significant Change From Baseline in Vital Signs** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings** _(time frame: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention)_
- **Time to Cmax (Tmax) of cis-CTB, AVI and hydroxypivalic acid (HPA)** _(time frame: Through 48 hours in period 1, 2, 3)_
- **Terminal Elimination Half-Life (t1/2) (if data permit) of cis-CTB, AVI and HPA** _(time frame: Through 48 hours in period 1, 2, 3)_
- **Apparent Oral Volume of Distribution (Vz/F) (if data permit) of cis-CTB, AVI and HPA** _(time frame: Through 48 hours in period 1, 2, 3)_
- **Apparent Oral Clearance (CL/F) (if data permit) of cis-CTB, AVI and HPA** _(time frame: Through 48 hours in period 1, 2, 3)_
- **Dose-Normalized Maximum Observed Plasma Concentration [Cmax(dn)] of HPA** _(time frame: Through 48 hours in period 1, 2, 3)_
- **Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast(dn)] of HPA** _(time frame: Through 48 hours in period 1, 2, 3)_
- **Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf(dn)] (if data permit)of HPA** _(time frame: Through 48 hours in period 1, 2, 3)_

## Locations (1)

- Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région de, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer clinical research unit - brussels|brussels|bruxelles-capitale, région de|belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06593054.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06593054*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*