A Phase 1, Open Label, Fixed Sequence Study to Investigate the Effect of Rabeprazole on the Pharmacokinetics of PF-08049820 in Healthy Chinese Adult Participants.
Overview
- Phase
- Phase 1
- Intervention
- PF-08049820
- Conditions
- Not specified
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08049820.
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This clinical study is designed to evaluate a study medicine called PF-08049820. The main aim is to understand how the body processes this medicine and whether giving it with another medicine, rabeprazole, affects how it behaves.
The study will take in healthy adult participants aged 18 to 65 years who are not able to have children. Eligible participants must weigh more than 50 kilograms (110 pounds) and have a Body Mass Index (BMI) between 18.5 and 27.9.
Each participant will receive two treatments:
- One treatment with PF-08049820 alone
- One treatment with PF-08049820 taken together with rabeprazole
Both medicines will be taken by mouth. Participants will stay at the study clinic for a few days during each treatment period. During these stays, the study team will collect blood samples to see how the body absorbs and processes the medicine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiogram.
- •BMI of 18.5-27.9 kg/m2; and a total body weight \>50 kg (110 lb).
- •Participants who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria
- •History or evidence of significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases.
- •Positive test for HIV, hepatitis B (HBsAg), or hepatitis C (HCVAb).
- •Active or latent tuberculosis (TB) infection or inadequate treatment history for TB.
- •Any medical or psychiatric condition, including active suicidal ideation in the past year or suicidal behavior in the past 5 years, that may increase risk or interfere with study participation.
- •Current use of prohibited medications or inability/unwillingness to use required medications.
Arms & Interventions
Treatment A
Participants will receive single oral dose of PF-08049820.
Intervention: PF-08049820
Treatment B
Participants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole.
Intervention: PF-08049820
Treatment B
Participants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole.
Intervention: Rabeprazole
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08049820.
Time Frame: Day 1 through Day 38-45
PK: Area under the plasma concentration (AUC) of PF-08049820
Time Frame: Day 1 through Day 38-45
Secondary Outcomes
- Number of participants with treatment emergent adverse events(First dose through Day 38-45)