Healthy Participant
Conditions
Brief summary
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.
Interventions
DRUGPF-07328948
Oral tablet
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1, 7 |
| Area under the plasma concentration (AUC) | Day 1, 7 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events | First dose through study completion, an average of 10 weeks |
Countries
China
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed