At a glance
ClinicalIndex Comparison Record- ✓Healthy male and/or female participants of non-childbearing potential
- ✓Age 18-70 years inclusive
- ✓Body mass index (BMI) of 17.5 to 30.5 kg/m^2 and total body weight >50 kg
- ✓Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and study procedures
- ✕Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- ✕Active bleeding or risk of bleeding including prior personal or familial history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder, or abnormal coagulation test results at screening
- ✕Significant risk factors for major bleeding including recent GI ulceration, malignant neoplasms at high risk of bleeding, recent brain/spinal injury or surgery, intracranial hemorrhage, esophageal varices, arteriovenous malformations, vascular aneurysms
- ✕Recent (within the past year) or active suicidal ideation/behavior
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS
In Brief
A Phase 1 clinical trial evaluating ARV-471 and Dabigatran etexilate for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this study is to understand if ARV-471 affects how a medicine called, dabigatran etexilate, gets absorbed or processed into the body in healthy adults. All participants in this study will receive one dose of dabigatran etexilate alone by mouth in Period 1. In Period 2, everyone will receive one dose of dabigatran etexilate by mouth approximately 90 minutes after receiving one dose of ARV-471 by mouth. The levels of dabigatran in Period 1 will be compared to the levels of dabigatran in Period 2. This will help us to determine if and how ARV-471 affects dabigatran gets absorbed into the body differently in healthy adults. All participants will stay at the study clinic for approximately 8 days and 7 nights.
Study Details
Timeline
Interventions
Experimental
Probe substrate