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
None
Disqualifiers
Cohort A and B.
Other protocol-defined Inclusion/Exclusion criteria apply.
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
Treatment groups
184 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 2 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