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Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

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ClinicalTrials.gov Identifier: NCT03873415
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects
Actual Study Start Date : January 25, 2019
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Arm Intervention/treatment
Experimental: Formulation A
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation B
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation C
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation D
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation E
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation F
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation G
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration

Experimental: Formulation H
Dosage formulation and area of release varies between arms
Drug: BMS-986165
Oral administration




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D [ Time Frame: Determined over 5 days ]
  2. Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D [ Time Frame: Determined over 5 days ]
  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D [ Time Frame: Determined over 5 days ]
  4. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D [ Time Frame: Determined over 5 days ]
  5. Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D [ Time Frame: Determined over 5 days ]

Secondary Outcome Measures :
  1. Vital signs of body temperature [ Time Frame: Up to 60 days ]
  2. Pulse rate [ Time Frame: Up to 60 days ]
  3. Physical examination [ Time Frame: Up to 60 days ]
  4. Incidence of adverse events (AE) [ Time Frame: Up to 90 days ]
  5. Incidence of serious adverse events (SAE) [ Time Frame: Up to 90 days ]
  6. Vital sign of respiratory rate [ Time Frame: Up to 60 days ]
  7. Vital sign of supine blood pressure [ Time Frame: Up to 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
  • Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
  • Acute diarrhea, or constipation within 3 weeks prior to randomization
  • Any major surgery within 4 weeks of randomization

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873415


Locations
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United States, Kentucky
Scintipharma
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03873415     History of Changes
Other Study ID Numbers: IM011-019
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases