A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986177 Oral Solution; Drug: [14C]BMS-986177 Solution for Infusion; Drug: BMS-986177 Spray-dried Dispersion Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT04965389

2021-000892-35 (EudraCT Number)

CV010-062

Details and patient eligibility

About

The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and fasted states, and to bridge the exposures seen using only the oral solution.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
• Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/ (height [m])²

Exclusion criteria

• History of gastrointestinal (GI) disease, upper or lower GI bleeding within 6 months, intracranial bleeding, tumor, aneurysms
• History or evidence of abnormal bleeding 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, or family history of coagulopathies
• Any acute or chronic medical illness considered clinically significant by the investigator
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, neurological or psychiatric disorder, as judged by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 4 patient groups

Treatment Sequence 1

Experimental group

Treatment:

Drug: BMS-986177 Spray-dried Dispersion Capsules

Drug: BMS-986177 Oral Solution

Drug: [14C]BMS-986177 Solution for Infusion

Treatment Sequence 2

Experimental group

Treatment:

Drug: BMS-986177 Spray-dried Dispersion Capsules

Drug: BMS-986177 Oral Solution

Drug: [14C]BMS-986177 Solution for Infusion

Treatment Sequence 3

Experimental group

Treatment:

Drug: BMS-986177 Spray-dried Dispersion Capsules

Drug: BMS-986177 Oral Solution

Drug: [14C]BMS-986177 Solution for Infusion

Treatment Sequence 4

Experimental group

Treatment:

Drug: BMS-986177 Spray-dried Dispersion Capsules

Drug: BMS-986177 Oral Solution

Drug: [14C]BMS-986177 Solution for Infusion