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NCT Number: NCT03254784

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Arthritic Psoriasis Arthritis Arthritis, Psoriatic Autoimmune Diseases Bone Diseases Connective Tissue Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be willing and able to complete all study-specific procedures and visits
  • Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
  • Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
  • Normal renal function at screening

Exclusion criteria

  • Women of childbearing potential not using an effective contraceptive method or are breastfeeding
  • Any significant acute or chronic medical illness
  • History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
  • History of headaches related to caffeine withdrawal, including energy drinks
  • History of syncope, orthostatic instability, or recurrent dizziness
  • Active TB requiring treatment or documented latent TB within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply.

Treatment and study plan

BMS-986165 Capsule

Drug

Oral capsule

BMS-986165 Tablet

Drug

Oral tablet

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time

    Time frame: 5 days

  2. AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time

    Time frame: 5 days

  3. 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

  4. Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time

    Time frame: 5 days

Secondary outcomes

  1. Adverse events measured by incidence

    Time frame: 26 days

  2. Serious adverse events measured by incidence

    Time frame: Approximately 55 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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