Home / Psoriasis / A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

  Purpose

The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.

Condition Intervention Phase
Systemic Lupus Erythematosus Arthritic Psoriasis Psoriasis Inflammatory Bowel Diseases Drug: BMS-986165 Capsule Drug: BMS-986165 Tablet Phase 1

Study Type: Interventional
Study Design:Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

  • Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time [ Time Frame: 5 days ]
  • AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time [ Time Frame: 5 days ]
  • Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time [ Time Frame: 5 days ]
  • Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time [ Time Frame: 5 days ]

Secondary Outcome Measures:

  • Adverse events measured by incidence [ Time Frame: 26 days ]
  • Serious adverse events measured by incidence [ Time Frame: Approximately 55 days ]

Estimated Enrollment:12
Actual Study Start Date:September 13, 2017
Estimated Study Completion Date:October 12, 2017
Estimated Primary Completion Date:October 11, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tablet-Capsule Crossover 1

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule

Oral capsule

Drug: BMS-986165 Tablet

Oral tablet
Experimental: Tablet-Capsule Crossover 2

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule

Oral capsule

Drug: BMS-986165 Tablet

Oral tablet
Experimental: Tablet-Capsule Crossover 3

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule

Oral capsule

Drug: BMS-986165 Tablet

Oral tablet
Experimental: Tablet-Capsule Crossover 4

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule

Oral capsule

Drug: BMS-986165 Tablet

Oral tablet
Experimental: Tablet-Capsule Crossover 5

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule

Oral capsule

Drug: BMS-986165 Tablet

Oral tablet
Experimental: Tablet-Capsule Crossover 6

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule

Oral capsule

Drug: BMS-986165 Tablet

Oral tablet

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