Kidney Failure, Chronic
Conditions
Keywords
Golcadomide
Brief summary
The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.
Interventions
DRUGGolcadomide
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must have severe renal impairment (RI). * Participant must have end-stage renal disease (ESRD). * Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between 18 and 40 kg/m2, (inclusive) at screening.
Exclusion criteria
* Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME). * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study * Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to Day 44 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 44 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 44 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 44 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to Day 60 |
| Number of participants with serious adverse events (SAEs) | Up to Day 60 |
| Number of participants with physical examination (PE) abnormalities | Up to Day 44 |
| Number of participants with vital sign abnormalities | Up to Day 44 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 44 |
| Number of participants with clinical safety laboratory abnormalities | Up to Day 44 |
| Dialysate clearance of golcadomide from plasma (CLD) | Day 1 |
Countries
United States
Contacts
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Outcome results
None listed