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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

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ClinicalTrials.gov Identifier: NCT03362411
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BMS-986205 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Arm Intervention/treatment
Experimental: BMS-986205 intact tablet orally then crushed tablet orally
Single, 100 mg dose
Drug: BMS-986205
Single 100 mg dose on Day 1 and Day 15

Experimental: BMS-986205 crushed tablet orally, then intact tablet orally
Single, 100 mg dose
Drug: BMS-986205
Single 100 mg dose on Day 1 and Day 15

Experimental: BMS-986205 intact tablet orally then suspension via NG tube
Single, 100 mg dose
Drug: BMS-986205
Single 100 mg dose on Day 1 and Day 15

Experimental: BMS-986205 suspension via NG tube then intact tablet orally
Single, 100 mg dose
Drug: BMS-986205
Single 100 mg dose on Day 1 and Day 15




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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

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.


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): NCT03362411


Locations
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United States, Texas
PPD Austin Clinic
Austin, Texas, United States, 78744
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: NCT03362411     History of Changes
Other Study ID Numbers: CA017-070
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Healthy participants
Healthy subjects
Additional relevant MeSH terms:
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Crush Injuries
Wounds and Injuries