A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other determinations. Females not of childbearing potential must have been amenorrhoeic for at least 12 months without an alternative medical cause and have follicle-stimulating hormone (FSH) levels of at least 40 IU/L or have undergone a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2 as measured at screening.
No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population.
Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.
Disqualifiers
Any significant medical condition or any condition that confounds the ability to interpret data from the study.
Participant has any condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk if the participant was to participate in the study.
Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.
Participants with any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
Trial design
Design model
Parallel
Treatments tested in this trial
BMS-986470
DrugSpecified dose on specified days
Placebo
DrugSpecified dose on specified days
Famotidine
DrugSpecified dose on specified days
Pantoprazole
DrugSpecified dose on specified days
Treatment groups
224 Participants
are divided into 5 treatment groupsGroup A: Cohort A Part 1Experimental treatment 2 interventions
Group B: Cohort A Part 2Experimental treatment 2 interventions
Group C: Cohort A Part 3Experimental treatment 3 interventions
Group D: Cohort B Part 1Experimental treatment 2 interventions
Group E: Cohort B Part 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs)
Time frame
Up to 26 months2
Number of participants with serious adverse events (SAEs)
Time frame
Up to 26 months3
Number of participants with AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Time frame
Up to 26 months4
Number of participants with AEs leading to discontinuation
Time frame
Up to 26 monthsSecondary outcomes
1
Maximum observed plasma concentration (Cmax)
Cohort A Parts 1 and 2 and Cohort B Part 1
Time frame
Up to Day 282
Area under the concentration-time curve (AUC)
Cohort A Parts 1 and 2 and Cohort B Part 1
Time frame
Up to Day 283
Time of maximum observed plasma concentration (Tmax)
Cohort A Parts 1 and 2 and Cohort B Part 1
Time frame
Up to Day 284
Dose proportionality of BMS-986470 for Cmax and AUC
Assessed by using the slope of a statistical linear relationship between the ln-transformed PK parameters AUC and Cmax and the ln-transformed dose will be fitted by using power model
Time frame
Up to Day 28Sponsors and contacts
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Source ClinicalTrials.gov