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A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05554237
Recruitment Status : Recruiting
First Posted : September 26, 2022
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 21, 2022
First Posted Date  ICMJE September 26, 2022
Last Update Posted Date May 22, 2023
Actual Study Start Date  ICMJE October 7, 2022
Estimated Primary Completion Date August 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2022)
  • Maximum Observed Plasma Concentration (Cmax) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Time to Cmax (Tmax) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Dose-Normalized Maximum Observed Plasma Concentration [Cmax(dn)] of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast(dn)] of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf(dn)] of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Terminal Elimination Half-Life (t1/2) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Apparent Oral Volume of Distribution (Vz/F) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Apparent Oral Clearance (CL/F) of cis-CTB, AVP, AVI and HPA [ Time Frame: Part-1: pre-dose to 24 hours post-dose for every period; Part-2: pre-dose to 8 hours post-dose on Day 1 and Day 6, and to 24 hours post-dose on Day 7 for each cohort ]
  • Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Causality of treatment-emergent adverse events (TEAEs) [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Withdrawals due to treatment-emergent adverse events (TEAEs) [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Frequency of abnormal laboratory findings [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Magnitude of abnormal laboratory findings [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Change from baseline in vital sign measurements [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  • Change from baseline in 12-lead ECG parameters [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2022)
  • Amount of unchanged drug excreted in urine within dosing interval of 8 hours for cis-CTB, AVP, AVI, and HPA (Ae,tau) [ Time Frame: Part-2: Day 6 only, pre-dose to 8 hours post-dose ]
  • Amount of unchanged drug excreted in urine within dosing interval of 8 hours as a percent of the administered dose for cis-CTB, AVP, AVI, and HPA (Ae,tau,%) [ Time Frame: Part-2: Day 6 only, pre-dose to 8 hours post-dose ]
  • Renal clearance of cis-CTB, AVP, AVI and HPA (CLr) [ Time Frame: Part-2: Day 6 only, pre-dose to 8 hours post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07612577 (PF-06264006 [CTB] + PF-07338233 [AVP]) IN HEALTHY ADULT PARTICIPANTS
Brief Summary

The purpose of this clinical trial is to learn about the pharmacokinetics, safety and tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants. CTB+AVP is a study medicine that is being developed to treat people with complicated urinary tract infections.

This study is seeking healthy adult male and female participants, 18-60 years of age, with a body weight > 50 kg and a BMI of 17.5 to 30.5 kg/m2.

Participants in Part-1 of the study will receive increasing single doses of CTB and/or AVP. Participants in Part-2 will receive increasing multiple doses of CTB+AVP three times a day for 7 days. The study team will monitor how each participant is doing with the study treatments via close monitoring in an in-patient setting. Experiences of people receiving CTB+AVP will be compared to those of people who do not. This will help determine if CTB+AVP is safe and well-tolerated at each dose of the study medicine.

Participants will take part in this study for a maximum of 12 weeks for Part-1 (up to 4 weeks for screening, up to 3 weeks of taking study medicine and up to 5 weeks for safety follow-up visit) and for a maximum of 10 weeks for Part-2 (up to 4 weeks for screening, up to 1 week of taking study medicine and up to 5 weeks for safety follow-up visit). During the duration of the study, blood samples for study medicine levels, and various measures for monitoring safety such as blood samples for clinical laboratory measurements, electrocardiograms and vital sign measurements will be taken.
Detailed Description

This is a 2-part study in healthy male and female adult participants.

Part-1 is to evaluate safety, tolerability and pharmacokinetics (PK) of 3 planned and 2 optional doses in 8 participants, in a 5-period sequential single dose design.

Part-2 is to evaluate safety, tolerability and PK of 1 planned and 2 optional cohorts in 8 participants each, in a multiple dose sequential design, with 7 days of repeated every 8 hours (q8h) dosing in each cohort. In addition, 2 optional cohorts in 6 participants each of Japanese descent and Chinese descent will also receive multiple doses of CTB+AVP repeated every 8 hours (q8h) for 7 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Participant and investigator-blinded and sponsor-open design for Part-1 and Part-2.
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Placebo
    Placebo
    Other Name: Placebo comparator
  • Drug: PF-07612577
    PF-07612577
    Other Name: CTB+AVP
  • Drug: PF-06264006
    PF-06264006
    Other Name: ceftibuten (CTB)
Study Arms  ICMJE
  • Experimental: PF-07612577
    Part-1: Dose 1, Dose 2, Dose 4, Dose 5 Part-2: Cohort 2-5
    Intervention: Drug: PF-07612577
  • Placebo Comparator: Placebo
    Part-1: Dose 1-5 Part-2: Cohort 2-4
    Intervention: Drug: Placebo
  • Experimental: PF-06264006
    Part-1: Dose 3, Dose 5
    Intervention: Drug: PF-06264006
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2022)		 44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 16, 2023
Estimated Primary Completion Date August 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  2. For optional Japanese cohort only: Japanese participants who have 4 Japanese biologic grandparents who were born in Japan
  3. For optional Chinese cohort only: Chinese participants who were born in mainland China, and both parents are of Chinese descent.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
  2. Known allergy to the cephalosporin group of antibiotics
  3. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
  4. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality [or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence)] that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
  5. A positive urine drug test
  6. Positive test result for SARS-CoV-2 infection at the time of screening or Day -1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05554237
Other Study ID Numbers  ICMJE C4691001
2021-005428-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP