A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
Public ClinicalTrials.gov record NCT05807490. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-07328948 IN HEALTHY ADULT PARTICIPANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 between doses in Period 1 and 2, and at least 7 days between doses in Period 2 and Period 3. In Sequence 2, there will be a minimum of 7 days between each dose.
Study identification
- NCT ID
- NCT05807490
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2023
- Primary completion
- Jul 9, 2024
- Completion
- Jul 9, 2024
- Last update posted
- Jul 18, 2024
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05807490, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05807490 live on ClinicalTrials.gov.