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NCT05807490 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
A Phase 1 study of Healthy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 2
- Study locations
NCT05807490 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 86 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05807490, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy participants. The purpose of Part B of this study is to understand the amount of PF-07328948 that would be available in the body after taking a single pill. The amount will be compared to the amount of PF-07328948 in a suspension in healthy adults. Part B will be conducted if the results of Part A support further study of PF-07328948. The study is seeking participants who: * are females who are not able to give birth to a child of 18 years of age or older. * are males of 18 years of age or older. * have a BMI of 20.0 to 35.0 kg/m2. * have total body weight of more than 50 kg (110 lbs). Participants in Part A will be randomly selected to receive either PF-07328948 or placebo (a pill that has no medicine in it). Participants in Part B will receive PF-07328948 as suspension and tablet form, both taken by mouth after food or during fasting. For a given participant in Part A, the total study is going to last up to about 12 weeks. This includes from the time of selection till the last follow-up phone call. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day -2 for around 19 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given. For a given participant in Part B, the total study is going to last up to about 10-12 weeks. Participants will stay overnight at the CRU for 23 days (Sequence 1) or 18 days (Sequence 2), starting with check-in. In Sequence 1, there will be a minimum of 10 days be
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-07328948
Study Locations (2)
Connecticut
- New Haven Clinical Research Unit - New Haven
Bruxelles-capitale, Région de
- Pfizer Clinical Research Unit - Brussels - Brussels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2024-07-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05807490
The ClinicalTrials.gov registry entry for NCT05807490 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05807490 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Connecticut, Bruxelles-capitale, Région de.
Frequently Asked Questions
What is clinical trial NCT05807490 about?
NCT05807490 is a clinical study titled "A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults". This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy participants. The purpose of Part B of this study is to understand the a...
What is the current status of trial NCT05807490?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2023-04-05. Estimated completion is 2024-07-10.
What conditions does trial NCT05807490 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05807490?
The interventions under investigation include: Placebo (DRUG), PF-07328948 (DRUG).
Who is sponsoring clinical trial NCT05807490?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05807490 being conducted?
This trial has 2 study locations across Connecticut, Bruxelles-capitale, Région de. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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