NCT04965389 is a Phase 1 clinical trial of BMS-986177 Oral Solution in Healthy Volunteers, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT04965389?

NCT04965389 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT04965389?

Interventions in NCT04965389: BMS-986177 Oral Solution, [14C]BMS-986177 Solution for Infusion, BMS-986177 Spray-dried Dispersion Capsules.

What condition does NCT04965389 study?

NCT04965389 studies Healthy Volunteers.

Is NCT04965389 still recruiting?

NCT04965389 is currently completed. Last updated 21 August 2023.

Are results published for NCT04965389?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-08-21 · How we verify

NCT04965389

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 21 August 2023

What this trial tests

Phase 1 trial testing BMS-986177 Oral Solution in Healthy Volunteers in 17 participants. Completed in 1 October 2021.

Timeline

16 July 2021

Primary endpoint
22 August 2021

1 October 2021

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	16 July 2021
Primary completion	22 August 2021
Estimated completion	1 October 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

BMS-986177 Oral Solution
[14C]BMS-986177 Solution for Infusion — full drug profile →
BMS-986177 Spray-dried Dispersion Capsules — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Absolute Bioavailability (F) Primary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

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).

Group	Value	95% CI
Treatment A: Oral Solution With IV	105	103 – 109
Treatment B: High Dose SDD Fasted	54.2	48.9 – 63.7
Treatment C: Low Dose SDD Fed	44.3	39.6 – 53.0
Treatment D: Low Dose SDD Fasted	58.2	52.8 – 70.7
Treatment E: High Dose SDD Fed	75.6	71.1 – 81.8

Number of Participants Experiencing Adverse Events (AEs) Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)

The number of participants experiencing AEs following single oral and IV administration. AEs are defined as any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Total participants with an adverse event

Group	Value	95% CI
Treatment A: Oral Solution With IV	8
Treatment B: High Dose SDD Fasted	2
Treatment C: Low Dose SDD Fed	2
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	2

Adverse events leading to discontinuation

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Number of Participants Experiencing Serious Adverse Events (SAE) Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 11 weeks)

The number of participants experiencing SAEs following single oral and IV administration. SAEs are defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or causes prolongation of existing hospitalization.

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Number of Participants Experiencing Abnormal Vital Sign Measurements Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Occurrence of abnormalities in vital sign measurements exceeding pre-defined thresholds following single oral and IV administration. The pre-defined thresholds include: Heart Rate(bpm) Value \> 100 and change from baseline \> 30, or Value \< 55 and change from baseline \< -15 Systolic Blood Pressure(mmHg) Value \> 140 and change from baseline \> 20, or Value \< 90 and change from baseline \< -20 Diastolic Blood Pressure(mmHg) Value \> 90 and change from baseline \> 10, or Value \< 55 and change from baseline \< -10 Respiratory Rate(breaths/min) Value \> 16 or change from baseline \> 10 Temper

Heart Rate (bpm) Value > 100 and change from baseline > 30

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Heart Rate (bpm) Value < 55 and change from baseline < -15

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Systolic Blood Pressure (mmHg) Value > 140 and change from baseline > 20

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	1
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Systolic Blood Pressure (mmHg) Value < 90 and change from baseline < -20

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	1

Diastolic Blood Pressure (mmHg) Value > 90 and change from baseline > 10

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Diastolic Blood Pressure (mmHg) Value < 55 and change from baseline < -10

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	2
Treatment C: Low Dose SDD Fed	1
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	1

Respiratory Rate (breaths/min) Value > 16 or change from baseline > 10

Group	Value	95% CI
Treatment A: Oral Solution With IV	13
Treatment B: High Dose SDD Fasted	10
Treatment C: Low Dose SDD Fed	10
Treatment D: Low Dose SDD Fasted	9
Treatment E: High Dose SDD Fed	7

Temperature (°C)Value > 38.3°C or change from baseline > 1.6°C

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Number of Participants With Abnormal Electrocardiograms (ECGs) Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

The number of participants with abnormal findings on ECGs following single oral and IV administration. Participants with ECG intervals outside of a pre-specified range and investigator identified ECG abnormalities will be listed. The following criteria will be used to determine ECG results that are outside of a pre-specified range: PR (msec)-Value \> 200; QRS (msec)-Value \> 120; QT (msec)-Value \> 500 or change from baseline \> 30; QTcF (msec)-Value \> 450 or change from baseline \> 30

Group	Value	95% CI
Treatment A: Oral Solution With IV	2
Treatment B: High Dose SDD Fasted	2
Treatment C: Low Dose SDD Fed	1
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	1

Number of Participants With Abnormal Physical Examinations Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

The number of participants with abnormal findings on physical examinations following single oral and IV administration.

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	2
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	1
Treatment E: High Dose SDD Fed	0

Number of Participants With Clinical Laboratory Test Abnormalities Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Number of participants with abnormalities in clinical lab test measurements exceeding pre-defined thresholds following single oral and IV administration. The pre-defined thresholds include: Alanine transaminase \> 3 × upper limit of normal (ULN) Aspartate transaminase \> 3 × ULN Alkaline phosphatase \> 1.5 × ULN Total bilirubin \> 2 × ULN

Alanine transaminase > 3 × upper limit of normal (ULN)

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Aspartate transaminase > 3 × ULN

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Alkaline phosphatase > 1.5 × ULN

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Total bilirubin > 2 × ULN

Group	Value	95% CI
Treatment A: Oral Solution With IV	0
Treatment B: High Dose SDD Fasted	0
Treatment C: Low Dose SDD Fed	0
Treatment D: Low Dose SDD Fasted	0
Treatment E: High Dose SDD Fed	0

Maximum Observed Plasma Concentration (Cmax) Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Cmax is defined as the maximum observed plasma concentration following single administration in the fed and fasted states to healthy participants.

Group	Value	95% CI
Treatment A: Oral Solution With IV	2929	± NA
Treatment B: High Dose SDD Fasted	1200	± NA
Treatment C: Low Dose SDD Fed	130	± NA
Treatment D: Low Dose SDD Fasted	185	± NA
Treatment E: High Dose SDD Fed	1696	± NA

Time of Maximum Observed Plasma Concentration (Tmax) Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Tmax is defined as the time of maximum observed plasma concentration in the fed and fasted states to healthy participants.

Group	Value	95% CI
Treatment A: Oral Solution With IV	1.27	0.500 – 4.00
Treatment B: High Dose SDD Fasted	4.00	1.50 – 5.00
Treatment C: Low Dose SDD Fed	4.00	1.00 – 6.00
Treatment D: Low Dose SDD Fasted	4.00	1.25 – 6.00
Treatment E: High Dose SDD Fed	5.00	4.00 – 10.0

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

AUC(0-T) is defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration following single administration in the fed and fasted states to healthy participants.

Group	Value	95% CI
Treatment A: Oral Solution With IV	30844	± NA
Treatment B: High Dose SDD Fasted	15855	± NA
Treatment C: Low Dose SDD Fed	1603	± NA
Treatment D: Low Dose SDD Fasted	2183	± NA
Treatment E: High Dose SDD Fed	21972	± NA

Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(INF)] Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

AUC(INF) is defined as area under the concentration-time curve from time zero extrapolated to infinity following single administration in the fed and fasted states to healthy participants

Group	Value	95% CI
Treatment A: Oral Solution With IV	31435	± NA
Treatment B: High Dose SDD Fasted	16464	± NA
Treatment C: Low Dose SDD Fed	1569	± NA
Treatment D: Low Dose SDD Fasted	2061	± NA
Treatment E: High Dose SDD Fed	22496	± NA

Apparent Clearance of Drug After Extravascular Administration (CLT/F) Secondary · Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

CLT/F is defined as the apparent clearance of drug after extravascular administration.

Group	Value	95% CI
Treatment A: Oral Solution With IV	6.36	± NA
Treatment B: High Dose SDD Fasted	12.1	± NA
Treatment C: Low Dose SDD Fed	15.9	± NA
Treatment D: Low Dose SDD Fasted	12.1	± NA
Treatment E: High Dose SDD Fed	8.89	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for all-cause mortality from their first dose to study completion (up to approximately 11 weeks). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 11 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A: Oral Solution With IV

Serious: 0/17 (0%)

Deaths: 0/17

Treatment B: High Dose SDD Fasted

Serious: 0/15 (0%)

Deaths: 0/15

Treatment C: Low Dose SDD Fed

Serious: 0/15 (0%)

Deaths: 0/15

Treatment D: Low Dose SDD Fasted

Serious: 0/15 (0%)

Deaths: 0/15

Treatment E: High Dose SDD Fed

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (16 terms — click to expand)

Reaction	System	Treatment A: Oral Solution…	Treatment B: High Dose SDD…	Treatment C: Low Dose SDD …	Treatment D: Low Dose SDD …	Treatment E: High Dose SDD…
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Joint injury	Injury, poisoning and procedural complications	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—
Vascular access site haemorrhage	Injury, poisoning and procedural complications	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04965389 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Absolute oral bioavailability of milvexian spray-dried dispersion formulation under fasted and fed conditions in healthy adult participants: An intravenous microtracer approach.
Jarugula P, Soleman S, Back H, Christopher LJ, et al · · 2024 · cited 3× · PMID 39450784 · DOI 10.1111/cts.70058

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04965389 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 21 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04965389.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04965389

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Healthy Volunteers

Other Bristol-Myers Squibb trials

Verify against primary sources