Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05554237
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2022-09-21
Brief Title:
A Study to Learn About the Study Medicine Called CTBAVP in Healthy Adult People
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to learn about the pharmacokinetics safety and tolerability of various single- and multiple-doses of CTBAVP in healthy adult participants CTBAVP 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 175 to 305 kgm2
Participants in Part-1 of the study will receive increasing single doses of CTB andor AVP Participants in Part-2 will receive increasing multiple doses of CTBAVP 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 CTBAVP will be compared to those of people who do not This will help determine if CTBAVP 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
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 175 to 305 kgm2
Participants in Part-1 of the study will receive increasing single doses of CTB andor AVP Participants in Part-2 will receive increasing multiple doses of CTBAVP 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 CTBAVP will be compared to those of people who do not This will help determine if CTBAVP 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 CTBAVP repeated every 8 hours q8h for 7 days
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 CTBAVP repeated every 8 hours q8h for 7 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005428-39 | EUDRACT_NUMBER | None | None |