A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/28/2019 |
| Start Date: | March 12, 2019 |
| End Date: | June 14, 2019 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
| Email: | Clinical.Trials@bms.com |
| Phone: | please email: |
A Randomized, Open Label, Parallel Design, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Formulations in Healthy Participants
Main Objective of this study is to compare the single intravenous (IV) infusion
pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and
CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference
formulation.
pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and
CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference
formulation.
Participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: A, B, C,
or D; followed by review of safety and tolerability data during and after the infusion. The
study will proceed with treatments A, and C unless one or more of these treatments shows poor
tolerability; in which case the study may proceed with treatment B or D in the follow-up
cohorts. Additional participants will be randomized equally to each of the treatments the
study will proceed with.
or D; followed by review of safety and tolerability data during and after the infusion. The
study will proceed with treatments A, and C unless one or more of these treatments shows poor
tolerability; in which case the study may proceed with treatment B or D in the follow-up
cohorts. Additional participants will be randomized equally to each of the treatments the
study will proceed with.
Inclusion Criteria:
- Participants must be willing to participate in the study and sign the informed consent
form (ICF).
- Participants must be willing and able to complete all study-specific procedures and
visits.
- Healthy participant, as determined by no clinically significant deviation from normal
in medical history, physical examination, ECGs, and clinical laboratory determinations
in the opinion of the investigator.
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 45 kg and ≤ 110
kg, at screening.
- Heart rate > 45 bpm and < 95 bpm at screening or baseline (within 30 minutes prior to
randomization).
- Systolic BP > 110 mmHg and < 140 mmHg at screening or baseline (within 30 minutes
prior to randomization).
- Normal renal function at screening as evidenced by an estimated glomerular filtration
rate > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology
Collaboration formula.
- Males and females, ages 18 or local age of majority to 40 years, inclusive.
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Diagnosis of fibromyalgia
- History of syncope, orthostatic instability, or recurrent dizziness
- History or family history of ocular disorders (eg, glaucoma)
- History of bleeding diathesis (unusual susceptibility to bleed [hemorrhage] mostly due
to hypocoagulability)
- Personal history or strong family history of sudden cardiac death, myocardial
infarction, or other heart disease considered to be clinically significant by the
investigator
- Any major surgery within 4 weeks of study drug administration
- History of Gilbert's Syndrome
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