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Hledat Study Connect

Active, Not Recruiting

A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants - IM031-002

Updated: 20 listopad, 2019   |   ClinicalTrials.gov

Kontaktujte nás, potřebujete-li pomoc
clinical.trials@bms.com

Tisk přehledného shrnutí

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Podrobnosti o hodnocení

  • Phase 1

    Fáze

  • Pohlaví

  • 18-55

    Věková skupina

  • Active, Not Recruiting

Možnosti léčby

Ramena studie
Přiřazená léčba
Experimental: Monotherapy MAD BMS-986318 or Placebo
Other: Placebo Drug: BMS-986318
Experimental: Monotherapy SAD BMS-986318 or Placebo
Other: Placebo Drug: BMS-986318

Klíčová kritéria způsobilosti

Inclusion Criteria: - Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator - Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days. - Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment. Exclusion Criteria: - Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration - Women of Child Bearing Potential (WOCBP) or women who are breastfeeding. - Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.

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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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