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Recruiting

A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults - MB006-017

Actualizada: 10 October, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-60

    Rango de edad

  • 1

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: BMS-963272 or Placebo every 12 hours (Q12H)
Drug: BMS-963272 Drug: Placebo
Experimental: BMS-963272 or Placebo every 8 hours (Q8H)
Drug: BMS-963272 Drug: Placebo
Experimental: BMS-963272 or Placebo once daily (QD)
Drug: BMS-963272 Drug: Placebo

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results. - Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive - Women (not of childbearing potential) and men aged 18 to 60 years, inclusive Exclusion Criteria: - Previous participation in the current study - Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study - Inability to tolerate the oLTT meal or to comply with oLTT testing conditions - Inability to tolerate oral medication - Inability to tolerate venipuncture and/or inadequate venous access - Women who are breastfeeding - Medical Conditions - History of lactose intolerance - Any significant (in the opinion of the investigator) acute or chronic illness - Type 1 or 2 diabetes - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population - Previous/Concomitant Therapy - Previous exposure to BMS-963272 Other protocol-defined inclusion/exclusion criteria could apply

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)

Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí

Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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