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Recruiting

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

Actualizada: 05 September, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-55

    Rango de edad

  • 1

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Monotherapy MAD BMS-986318 or Placebo
Other: Placebo Drug: BMS-986318
Experimental: Monotherapy SAD BMS-986318 or Placebo
Other: Placebo Drug: BMS-986318

Criterios clave de elegibilidad

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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