A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
NCT ID: NCT05788328
Last Updated: 2024-11-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
16 participants
INTERVENTIONAL
2023-03-27
2023-09-11
Brief Summary
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The study is seeking for participants who are:
* Male or female who are 18 years of age or older.
* Healthy but are overweight or obese. Participants will receive dabigatran and rosuvastatin as single doses by mouth 3 times during the study. The amount of the study medicine PF-07081532 will be adjusted over time until any interactions are seen.
PF-07081532 is taken daily by mouth in 8 Study Periods while admitted into the study clinic over 53 days. Once discharged from the study clinic, participants will have a follow-up visit 7 to 10 days post last dose of study medicine. Then another follow-up via telephone contact, 28 to 35 days post last dose of study medicine.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Period 1
Participants will receive dabagatrin etexilate (DE) as a single dose
Dabigatran etexilate (DE)
Dabigatran etexilate (DE) as oral capsule
Period 2
Participants will receive rosuvastatin as a single dose
Rosuvastatin
Rosuvastatin as oral tablet
Period 3
Participants will receive PF-07081532 daily titrated
PF-07081532
PF-07081532 as oral tablets
Period 4
Participants will receive PF-07081532 daily and DE as a single dose
Dabigatran etexilate (DE)
Dabigatran etexilate (DE) as oral capsule
PF-07081532
PF-07081532 as oral tablets
Period 5
Participants will receive PF-07081532 daily and rosuvastatin as a single dose
Rosuvastatin
Rosuvastatin as oral tablet
PF-07081532
PF-07081532 as oral tablets
Period 6
Participants will receive PF-07081532 daily titrated
PF-07081532
PF-07081532 as oral tablets
Period 7
Participants will receive PF-07081532 daily and DE as a single dose
Dabigatran etexilate (DE)
Dabigatran etexilate (DE) as oral capsule
PF-07081532
PF-07081532 as oral tablets
Period 8
Participants will receive PF-07081532 daily and rosuvastatin as a single dose
Rosuvastatin
Rosuvastatin as oral tablet
PF-07081532
PF-07081532 as oral tablets
Interventions
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Dabigatran etexilate (DE)
Dabigatran etexilate (DE) as oral capsule
Rosuvastatin
Rosuvastatin as oral tablet
PF-07081532
PF-07081532 as oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. BMI: ≥25.0 kg/m2 at Screening
3. Stable body weight, defined as \<5 kg change (per participant report) for 90 days before Screening
Exclusion Criteria
2. Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening
3. History of myocardial infarction, unstable angina, arterial revascularization, mechanical prosthetic heart valve, stroke, New York Association Functional Class II-IV heart failure, or transient ischemic attack within 6 months of Screening
4. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin)
5. Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment
6. Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis
7. Symptomatic gallbladder disease
8. Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
9. History of depressive disorder or history of other severe psychiatric disorders within the last 2 years from Screening
10. Any lifetime history of a suicide attempt
11. Known medical history of active liver disease, or prior known drug-induced liver injury
12. History of HIV infection
13. Recent history of bleeding, or risks of bleeding, or abnormal coagulation test (INR \>1.3) result at Screening
14. Use of prohibited medications
15. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest
16. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study result
17. Participants with clinical laboratory test abnormalities at Screening
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Qps-Mra, Llc
South Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3991047
Identifier Type: -
Identifier Source: org_study_id
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