Status:
COMPLETED
A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral ...
Eligibility Criteria
Inclusion
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
- Body mass index (BMI equals to \[=\] weight/height\^2) between 18 and 30 kilograms per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kg at screening
- Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Treatment Period 1. If the results of the safety laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant except as specified in Exclusion Criteria 2. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine pregnancy test on Day 1 of Treatment Period 1
- Before randomization, a woman must be either: a) Not of childbearing potential defined as: postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level greater than (\>) 40 international units per liter IU/L or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal replacement therapy (HRT), however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; b) Of childbearing potential and; practicing a highly effective method of contraception (failure rate of less than \[\<\] 1 percent \[%\] per year when used consistently and correctly) for at least 3 months prior to the study entry and; agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
- During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/ film/cream/suppository)
Exclusion
- History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol-specified assessments. This may include but is not limited to any known bleeding or clotting disorder, a history of arterial or venous thrombosis, liver or renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplasm, metabolic disturbances, or poor venous access
- Clinically significant abnormal values for hematology, coagulation, clinical chemistry, or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee. Any of the following laboratory results outside of the normal ranges specified below at screening or Day -1 of Treatment Period 1 which must be confirmed by repeat: Hemoglobin or hematocrit less than (\<) lower limit of normal; Platelet count \< lower limit of normal; activated partial thromboplastin time (aPTT) or prothrombin time (PT) \>1.2\*upper limit of normal (ULN)
- Use of any agent, including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other anti-platelet agents, anticoagulants, fish oil capsules, ginkgo or any agent that can potentially increase the risk of bleeding within 14 days prior to the first dose of study drug administration
- History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
- History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
- Woman with history of excessive menstrual bleeding as determined by the investigator or appropriate designee
- Does not tolerate venipuncture
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04844424
Start Date
April 14 2021
End Date
July 12 2022
Last Update
May 23 2025
Active Locations (1)
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1
PRA Health Sciences
Salt Lake City, Utah, United States, 84124