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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2023-06-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Participant and investigator-blinded and sponsor-open design for Part-1 and Part-2.

Study Groups

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PF-07612577

Part-1: Dose 1, Dose 2, Dose 4, Dose 5 Part-2: Cohort 2-5

Group Type EXPERIMENTAL

PF-07612577

Intervention Type DRUG

PF-07612577

Placebo

Part-1: Dose 1-5 Part-2: Cohort 2-4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

PF-06264006

Part-1: Dose 3, Dose 5

Group Type EXPERIMENTAL

PF-06264006

Intervention Type DRUG

PF-06264006

Interventions

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Placebo

Intervention Type DRUG

PF-07612577

Intervention Type DRUG

PF-06264006

Intervention Type DRUG

Other Intervention Names

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Placebo comparator CTB+AVP ceftibuten (CTB)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes