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
Bristol-Myers Squibb
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria \- Cohort A. i) 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. ii) Body mass index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive. BMI = weight (kg)/ (height \[m\])\^2 as measured at sc…
Interventions
- DrugBMS-986470
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
- DrugFamotidine
Specified dose on specified days
Locations (19)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California San Diego - La JollaLa Jolla, California
- UCSF Benioff Children's Hospital OaklandOakland, California
- Yale-New Haven HospitalNew Haven, Connecticut
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- Local Institution - 0034Chicago, Illinois