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A First-in-Human Study to Assess Single and Multiple Doses of BMS-986209 in Healthy Participants - CV017-003
Updated: 5 November, 2019 | ClinicalTrials.gov
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Not Yet Recruiting
Inclusion Criteria: - Signed informed consent form - Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. (BMI = weight (kg)/height[m])2. - Normal renal function at screening. - Female participants not of child-bearing potential. - Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception: to use a condom during the intervention period and for at least 92 days after the last dose of study intervention. Azoospermic males are exempt from contraceptive requirements. - Males with a pregnant or breastfeeing partner must agree to remain abstinent from penile vaginal intercourse or use a male condom during each episode of such intercourse, during the intervention period and for at least 92 days after the last dose of study intervention. - Male participants must refrain from donating sperm during the intervention period and for at least 92 days after the last dose of study intervention. Exclusion Criteria: - Women who are of childbearing potential. - Women who are breastfeeding. - Any acute or chronic medical illness. - History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for a 1-week duration in the last month prior to study treatment administration). - History of heart disease or conduction disorders. - Head injury in the last 2 years, intracranial tumor, or aneurysm. - Current or history of rectal bleeding, hematemesis, or hematuria. - Known abdominal aneurysm. - History of gastroesophageal reflux disease, inflammatory bowel disease or any gastrointestinal disease that could impact the absorption of study treatment. - History or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding, such as epistaxis. - Personal or family history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies. - History of systemic lupus erythematosus or any other autoimmune diseases. - Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study. - Donation of blood to a blood bank or in a clinical study (except a screening visit or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only). - Current or any history of blood transfusion. - Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration). - Current or history of drug or alcohol abuse. Other protocol-defined inclusion/exclusion criteria may apply.