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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986205

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Austin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured by plasma concentration.	Up to 22 days
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.	Measured by plasma concentration.	Up to 22 days
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.	Measured by plasma concentration.	Up to 22 days
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.	Measured by plasma concentration.	Up to 22 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of non-serious Adverse Events (AEs).	Safety and tolerability as measured by incidence of non-serious AEs.	Up to 22 days
Incidence of Serious Adverse Events (SAEs).	Safety and tolerability as measured by incidence of SAEs.	Up to 22 days
Number of participants with clinical laboratory abnormalities.		Up to 22 days
Number of participants with vital sign abnormalities.		Up to 22 days
Number of participants with electrocardiogram (ECG) abnormalities.		Up to 22 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Healthy subjects; Healthy participants
• Additional Relevant MeSH Terms: Wounds and Injuries; Crush Injuries; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Linrodostat
• Other Study ID Numbers: CA017-070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No