- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07455240
A Study to Learn About How the Body Processes the Study Medicine Called PF-07328948 in Healthy Chinese Adults
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of PF-07328948 Following Multiple Oral Doses in Healthy Chinese Adult Participants
The purpose of this study is to learn about:
- How PF-07328948 is changed and removed from the body after taking
- Safety of PF-07328948
- The extent to which undesirable effects can be tolerated after taking PF-07328948 for the possible treatment of heart failure
This study is seeking participants who:
- Are healthy Chinese adults who are aged 18 years old and older
- Have body mass index from 18.5 to under 28 kilograms/meter square
- Have a total body weight over 50 kilograms (110 pounds)
- Do not have a history of blood clots blocking an artery or vein
All participants in this study will receive oral daily PF-07328948 at the study clinic for 7 consecutive days.
The experiences of the participants receiving the study medicine will be looked at. This will help to see if the study medicine is safe.
Participants will take part in this study for around 10 weeks. During this time, participants will have 1 study visit at the study clinical and 1 contact over the phone.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 101100
- Beijing Friendship Hospital, Capital Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Females of non-childbearing potential and males, aged 18 years or older at the time of screening, who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECG.
- BMI of ≥ 18.5 and < 28.0 kg/m2; and a total body weight >50 kg (110 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion Criteria:
- 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).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HBV-DNA, HCVAb, HCV-RNA, or syphilis.
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of DVT, pulmonary embolism, or arterial thrombosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Participants will receive oral daily PF-07328948 tablet for 7 consecutive days.
|
Oral tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1, 7
|
Day 1, 7
|
|
Area under the plasma concentration (AUC)
Time Frame: Day 1, 7
|
Day 1, 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with treatment emergent adverse events
Time Frame: First dose through study completion, an average of 10 weeks
|
First dose through study completion, an average of 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C4921010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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