BMS-986470
DrugSpecified dose on specified days
NCT Number: NCT06481306
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Local Institution - 0050, Vancouver, British Columbia, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cohort A:
Cohort B:
i) Hemoglobin ≥ 5.5 and ≤ 12 g/dL (males) or ≥ 5.5 and ≤ 10.6 g/dL (females). ii) Absolute neutrophil count ≥ 1500/μL. iii) Platelet count ≥ 100 × 10^3/μL. iv) Absolute reticulocyte count > 100 × 10^3/μL or > 50 × 10^3/μL if taking hydroxyurea.
Exclusion criteria
Cohort A:
Cohort B:
Cohort A and B:
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Time frame: Up to 26 months
Time frame: Up to 26 months
Time frame: Up to 26 months
Time frame: Up to 26 months
Time frame: Up to 26 months
Time frame: Up to 28 days after last dose
Time frame: Up to 28 days after last dose
Time frame: Up to 28 days after last dose
Time frame: Up to Day 28
Cohort A Parts 1 and 2 and Cohort B Part 1
Time frame: Up to Day 28
Cohort A Parts 1 and 2 and Cohort B Part 1
Time frame: Up to Day 28
Cohort A Parts 1 and 2 and Cohort B Part 1
Time frame: Up to Day 28
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 26 months
Cohort A Part 2, Cohort B Parts 1 and 2
Time frame: Up to Day 28
Cohort A Part 2
Time frame: Up to 26 months
Cohort A Part 2, Cohort B Parts 1 and 2
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Time frame: Up to 26 months
Cohort B
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Bristol-Myers Squibb
Industry
A Phase 1/2a, First-in-human, Randomized, Double-blinded, Placebo-controlled, Dose-finding Study in Healthy Volunteers and Participants With Sickle Cell Disease to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, pH and Food Effect, and Preliminary Efficacy of BMS-986470
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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