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Completed

NCT Number: NCT03873415

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Scintipharma

Lexington, Kentucky, 40504, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

BMS-986165

Drug

Oral administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2019
Registry last updated
Nov 26, 2019

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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