Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: PF-07612577 Drug: PF-06264006 Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Official Title: 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
Actual Study Start Date : October 7, 2022
Estimated Primary Completion Date : August 16, 2023
Estimated Study Completion Date : August 16, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PF-07612577
Part-1: Dose 1, Dose 2, Dose 4, Dose 5 Part-2: Cohort 2-5
 Drug: PF-07612577
PF-07612577
Other Name: CTB+AVP
Placebo Comparator: Placebo
Part-1: Dose 1-5 Part-2: Cohort 2-4
 Drug: Placebo
Placebo
Other Name: Placebo comparator
Experimental: PF-06264006
Part-1: Dose 3, Dose 5
 Drug: PF-06264006
PF-06264006
Other Name: ceftibuten (CTB)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. Frequency of abnormal laboratory findings [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  16. Magnitude of abnormal laboratory findings [ Time Frame: Part-1: 0 hours up to 8 weeks; Part-2: 0 hours up to 6 weeks ]
  17. 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 ]
  18. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Renal clearance of cis-CTB, AVP, AVI and HPA (CLr) [ Time Frame: Part-2: Day 6 only, pre-dose to 8 hours post-dose ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05554237


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Layout table for location information
Belgium
Brussels Clinical Research Unit Recruiting
Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05554237    
Other Study ID Numbers: C4691001
2021-005428-39 ( EudraCT Number )
First Posted: September 26, 2022    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ceftibuten
Anti-Bacterial Agents
Anti-Infective Agents