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

NCT06593054 | Completed Phase 1 FDA Drug

• 2 other identifiers: C46910032023-507117-10-00
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

ceftibuten; avibactam prodrug; relative bioavailability

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration [Cmax] of cis-CTB and AVI following test formulation administration in fasted or fed state

  Cmax is estimated based on the plasma concentrations for test and reference formulation

  Through 48 hours in period 1, 2, 3

• Dose-normalized Maximum Observed Plasma Concentration [Cmax(dn)] of cis-CTB and AVI following test/ reference formulation administration

  Cmax is estimated based on the plasma concentrations for test and reference formulation and then normalized by dose

  Through 48 hours in period 1, 2, 3

• 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

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  Through 48 hours in period 1, 2, 3

• 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

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) normalized by dose

  Through 48 hours in period 1, 2, 3

• 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

  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.

  Through 48 hours in period 1, 2, 3

• 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

  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

  Through 48 hours in period 1, 2, 3

Secondary Outcomes (14)

• Number of participants with Treatment Emergent Adverse Events (TEAE)

  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 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 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 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 the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

Study Arms (3)

CTB-AVP Capsules, fasted

EXPERIMENTAL

Reference formulation of CTB-AVP in capsules, administered under fasted conditions

Drug: Ceftibuten; Drug: Avibactam prodrug

CTB-AVP Tablet , fasted

EXPERIMENTAL

Test formulation of CTB-AVP in tablets, administered under fasted conditions

Drug: CTB-AVP in Tablet

CTB-AVP Tablet , fed

EXPERIMENTAL

Test formulation of CTB-AVP in tablets, administered under fed conditions

Drug: CTB-AVP in Tablet

Interventions

Ceftibuten DRUG

Ceftibuten dihydrate, formulated in capsules

CTB-AVP Capsules, fasted

Avibactam prodrug DRUG

Avibactam prodrug, formulated in capsules

CTB-AVP Capsules, fasted

CTB-AVP in Tablet DRUG

ceftibuten and avibactam prodrug, in Tablet formulation

CTB-AVP Tablet , fasted; CTB-AVP Tablet , fed

Eligibility Criteria

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

You may qualify if:

• 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).
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Have a body-mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Ceftibuten; Tablets

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: September 19, 2024
• Study Start: July 29, 2024
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)