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

NCT04965389 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CV010-0622021-000892-35
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Bioavailability; BMS-986177; 14C-Microtracer; Milvexian

Outcome Measures

Primary Outcomes (1)

• Absolute Bioavailability (F)

  Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).

  Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Secondary Outcomes (22)

• Number of Participants Experiencing Adverse Events (AEs)

  Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)

• Number of Participants Experiencing Serious Adverse Events (SAE)

  Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)

• Number of Participants Experiencing Abnormal Vital Sign Measurements

  Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

• Number of Participants With Abnormal Electrocardiograms (ECGs)

  Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

• Number of Participants With Abnormal Physical Examinations

  Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

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

Treatment Sequence 2

EXPERIMENTAL

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

Treatment Sequence 3

EXPERIMENTAL

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

Treatment Sequence 4

EXPERIMENTAL

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

Interventions

BMS-986177 Oral Solution DRUG

Specified dose on specified days

Also known as: Milvexian, JNJ-70033093

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

[14C]BMS-986177 Solution for Infusion DRUG

Specified dose on specified days

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

BMS-986177 Spray-dried Dispersion Capsules DRUG

Specified dose on specified days

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

milvexian

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trails@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: July 16, 2021
• Primary Completion: August 22, 2021
• Study Completion: October 1, 2021
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2022-09

Locations

GB (1)