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Hledat Study Connect

Recruiting

Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants - CN016-0001

Updated: 23 červenec, 2026   |   ClinicalTrials.gov

Tisk přehledného shrnutí

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Podrobnosti o hodnocení

  • Phase 1

    Fáze

  • Pohlaví

  • 18-55

    Věková skupina

  • 1

    Umístění

  • Recruiting

Možnosti léčby

Ramena studie
Přiřazená léčba
Experimental: Arm A
Drug: BMS-986533, Placebo
Experimental: Arm B
Drug: BMS-986533, Placebo
Experimental: Arm C
Drug: BMS-986533, Famotidine
Experimental: Arm D
Drug: BMS-986533, Dabigatran Etexilate, Rosuvastatin

Klíčová kritéria způsobilosti

Inclusion Criteria: - Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg. - Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status. - A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF. Exclusion Criteria: - Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication). - Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease. - Participants must not have any major surgery within 3 months of study intervention administration. - Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery). - Other protocol defined inclusion/exclusion criteria applies.

Důrazně doporučujeme kontaktovat BMS a oznámit vedlejší účinky / nežádoucí příhody
Zde jsou definovány vedlejší účinky / nežádoucí příhody a další příhody, které by měly být hlášeny
Nahlásit vedlejší účinky / nežádoucí příhody nebo stížnosti na kvalitu produktu: lékařské informace

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