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Recruiting

A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis - IM027-1014

Oppdatert: 7 januar, 2025   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 1

    Fase

  • Kjønn

  • 18-84

    Aldersgruppe

  • 4

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Group A and C
Drug: BMS-986278
Experimental: Group B: Period 1
Drug: BMS-986278
Experimental: Group B: Period 2
Drug: BMS-986278

Nøkkelkriterier for kvalifikasjon

Inclusion Criteria: - Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight. - Severe Renal Impaired Participants: 1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute. 2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening. 3. Participant must be medically stable for at least 1 month before study intervention administration. - Participants with ESRD: 1. Participant has ESRD as defined by an eGFR < 15 mL/min at screening. 2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening. 3. Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening. - Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute. - Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation). Exclusion Criteria: - Participant with any significant medical condition, laboratory abnormality, or psychiatric illness. - Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy). - Individuals who are of childbearing potential, breastfeeding, or currently pregnant. - Other protocol defined inclusion/exclusion criteria apply.

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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046