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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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03254784
First received: August 17, 2017
Last updated: NA
Last verified: August 2017
History: No changes posted
  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
Anticipated Study Start Date: September 11, 2017
Estimated Study Completion Date: October 10, 2017
Estimated Primary Completion Date: October 9, 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03254784

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Netherlands
Local Institution Not yet recruiting
Groningen, Netherlands, 9728 NZ
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03254784     History of Changes
Other Study ID Numbers: IM011-031
Study First Received: August 17, 2017
Last Updated: August 17, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on August 18, 2017