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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04965389
Collaborator
(none)
17
Enrollment
1
Location
4
Arms
2.5
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Oral solution
  • Drug: [14C]BMS-986177 Solution for Infusion
  • Drug: BMS-986177 Spray-dried Dispersion Capsules
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Assess the Absolute Oral Bioavailability of Milvexian Using a 14C-Microtracer and Oral Solution in Healthy Participants With Additional Food Effect Comparison of a Spray-Dried Dispersion Formulation of Milvexian in Capsules
Actual Study Start Date :
Jul 16, 2021
Actual Primary Completion Date :
Aug 22, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Sequence 1

Drug: Oral solution
Specified dose on specified days
Other Names:
  • BMS-986177
  • Milvexian
  • JNJ-70033093
  • Drug: [14C]BMS-986177 Solution for Infusion
    Specified dose on specified days.

    Drug: BMS-986177 Spray-dried Dispersion Capsules
    Specified dose on specified days

    Experimental: Sequence 2

    Drug: Oral solution
    Specified dose on specified days
    Other Names:
  • BMS-986177
  • Milvexian
  • JNJ-70033093
  • Drug: [14C]BMS-986177 Solution for Infusion
    Specified dose on specified days.

    Drug: BMS-986177 Spray-dried Dispersion Capsules
    Specified dose on specified days

    Experimental: Sequence 3

    Drug: Oral solution
    Specified dose on specified days
    Other Names:
  • BMS-986177
  • Milvexian
  • JNJ-70033093
  • Drug: [14C]BMS-986177 Solution for Infusion
    Specified dose on specified days.

    Drug: BMS-986177 Spray-dried Dispersion Capsules
    Specified dose on specified days

    Experimental: Sequence 4

    Drug: Oral solution
    Specified dose on specified days
    Other Names:
  • BMS-986177
  • Milvexian
  • JNJ-70033093
  • Drug: [14C]BMS-986177 Solution for Infusion
    Specified dose on specified days.

    Drug: BMS-986177 Spray-dried Dispersion Capsules
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Absolute oral bioavailability of milvexian oral solution (fasted) [Up to 15 days]

      Derived from plasma concentration vs. time and urinary excretion data. Measured by liquid chromatography/mass spectrometry (LC-MS/MS) analysis.

    2. Absolute oral bioavailability of milvexian dose 1 spray-dried dispersion (SDD) (fasted) [Up to 15 days]

      Derived from plasma concentration vs. time and urinary excretion data. Measured by liquid chromatography/mass spectrometry (LC-MS/MS) analysis.

    3. Absolute oral bioavailability of milvexian dose 1 spray-dried dispersion (SDD) (fed) [Up to 15 days]

      Derived from plasma concentration vs. time and urinary excretion data. Measured by liquid chromatography/mass spectrometry (LC-MS/MS) analysis.

    4. Absolute oral bioavailability of milvexian dose 2 spray-dried dispersion (SDD) (fasted) [Up to 15 days]

      Derived from plasma concentration vs. time and urinary excretion data. Measured by liquid chromatography/mass spectrometry (LC-MS/MS) analysis.

    5. Absolute oral bioavailability of milvexian dose 2 spray-dried dispersion (SDD) (fed) [Up to 15 days]

      Derived from plasma concentration vs. time and urinary excretion data. Measured by liquid chromatography/mass spectrometry (LC-MS/MS) analysis.

    Secondary Outcome Measures

    1. Number of participants with Adverse Events (AEs) [Up to 3 days after the last dose of the drug]

    2. Number of participants with Serious Adverse Events (SAEs) [Up to 3 days after the last dose of the drug]

    3. Number of participants with clinically significant changes in vital signs: Body temperature [Up to 3 days after the last dose of the drug]

    4. Number of participants with clinically significant changes in vital signs: Respiratory rate [Up to 3 days after the last dose of the drug]

    5. Number of participants with clinically significant changes in vital signs: Blood pressure [Up to 3 days after the last dose of the drug]

    6. Number of participants with clinically significant changes in vital signs: Heart rate [Up to 3 days after the last dose of the drug]

    7. Number of participants with clinically significant changes in ECG parameters: PR interval [Up to 3 days after the last dose of the drug]

      PR interval is the time from the onset of the P wave to the start of the QRS complex

    8. Number of participants with clinically significant changes in ECG parameters: QRS [Up to 3 days after the last dose of the drug]

      QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

    9. Number of participants with clinically significant changes in ECG parameters: QT interval [Up to 3 days after the last dose of the drug]

      The QT interval is the time from the start of the Q wave to the end of the T wave

    10. Number of participants with clinically significant changes in ECG parameters: QTcF [Up to 3 days after the last dose of the drug]

      QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

    11. Number of participants with clinically significant changes in ECG parameters: QRS axis [Up to 3 days after the last dose of the drug]

    12. Number of participants with physical examination abnormalities [Up to 3 days after the last dose of the drug]

    13. Number of participants with clinically significant changes in laboratory values: Hematology tests [Up to 3 days after the last dose of the drug]

    14. Number of participants with clinically significant changes in laboratory values: Coagulation [Up to 3 days after the last dose of the drug]

    15. Number of participants with clinically significant changes in laboratory values: Chemistry tests [Up to 3 days after the last dose of the drug]

    16. Number of participants with clinically significant changes in laboratory values: Urinalysis [Up to 3 days after the last dose of the drug]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 may apply.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Local InstitutionNottinghamUnited KingdomNG11 6JS

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04965389
    Other Study ID Numbers:
    • CV010-062
    • 2021-000892-35
    First Posted:
    Jul 16, 2021
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Bristol-Myers Squibb
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021