A Study to Evaluate the Pharmacokinetics and Safety of Golcadomide in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-84
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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/exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Golcadomide

    Drug

    Specified dose on specified days

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum observed concentration (Cmax)

Time frame
Up to Day 44
2

Time of maximum observed plasma concentration (Tmax)

Time frame
Up to Day 44
3

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Time frame
Up to Day 44
4

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time frame
Up to Day 44

Secondary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to Day 60
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to Day 60
3

Number of participants with physical examination (PE) abnormalities

Time frame
Up to Day 44
4

Number of participants with vital sign abnormalities

Time frame
Up to Day 44

Other outcomes

Sponsors and contacts

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