- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07284173
A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Healthy Chinese Adults.
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100050
- Beijing Friendship Hospital Affiliate of Capital University
-
Beijing, Beijing Municipality, China, 101100
- Beijing Friendship Hospital Affiliate of Capital University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment A
Participants will receive single oral dose of PF-08049820.
|
Oral tablets
|
|
Experimental: Treatment B
Participants will receive rabeprazole for 5 days followed by a single oral dose of PF-08049820 and rabeprazole.
|
Oral tablets
Other Names:
Oral tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08049820.
Time Frame: Day 1 through Day 38-45
|
Day 1 through Day 38-45
|
|
PK: Area under the plasma concentration (AUC) of PF-08049820
Time Frame: Day 1 through Day 38-45
|
Day 1 through Day 38-45
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with treatment emergent adverse events
Time Frame: First dose through Day 38-45
|
First dose through Day 38-45
|
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 (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Immune System Diseases
- Hypersensitivity, Immediate
- Hypersensitivity
- Skin Diseases
- Skin Diseases, Genetic
- Skin Diseases, Eczematous
- Dermatitis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Dermatitis, Atopic
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Sulfoxides
- Sulfur Compounds
- Organic Chemicals
- Pyridines
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Benzimidazoles
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Rabeprazole
Other Study ID Numbers
- C6231005
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
product manufactured in and exported from the U.S.
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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