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Completed

NCT Number: NCT03362411

A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet

The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive a single dose of BMS-986205 twice during the course of the study.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed written consent form.
  • Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
  • Women participants must have documented proof they are not of childbearing potential.
  • Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986205, and for a total of 110 days after the last dose of BMS-986205; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
  • Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2).
  • Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion criteria

  • Women who are of childbearing potential or breastfeeding.
  • Any significant acute or chronic illness.
  • Active tuberculosis (TB) requiring treatment, documented latent TB within the previous 3 years, or evidence of a past TB infection without documented adequate therapy. All participants will be required to have a QuantiFERON -TB Gold test performed at screening.
  • History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital hemolytic anemias.
  • History of cardiac arrhythmias and/or autonomic instability.
  • History of pulmonary, renal or liver disease.
  • History of Gilbert's Syndrome.
  • Recent (within 6 months of study drug administration) history of smoking or current smokers, including use of electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
  • Participants with active, known or suspected autoimmune disease. Participants with vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may enroll.
  • Major surgery within 4 weeks of study drug administration.

Other protocol defined inclusion/exclusion criteria could apply.

Treatment and study plan

BMS-986205

Drug

Single 100 mg dose on Day 1 and Day 15

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.

    Time frame: Up to 22 days

    Measured by plasma concentration.

  2. Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.

    Time frame: Up to 22 days

    Measured by plasma concentration.

  3. Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.

    Time frame: Up to 22 days

    Measured by plasma concentration.

  4. Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.

    Time frame: Up to 22 days

    Measured by plasma concentration.

Secondary outcomes

  1. Incidence of non-serious Adverse Events (AEs).

    Time frame: Up to 22 days

    Safety and tolerability as measured by incidence of non-serious AEs.

  2. Incidence of Serious Adverse Events (SAEs).

    Time frame: Up to 22 days

    Safety and tolerability as measured by incidence of SAEs.

  3. Number of participants with clinical laboratory abnormalities.

    Time frame: Up to 22 days

  4. Number of participants with vital sign abnormalities.

    Time frame: Up to 22 days

  5. Number of participants with electrocardiogram (ECG) abnormalities.

    Time frame: Up to 22 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Randomized, Open-Label Study to Assess the Relative Bioavailability of a Single 100-mg Dose of BMS-986205 in Healthy Participants When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube Compared to an Intact Tablet of Similar Dose

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
Feb 23, 2018

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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