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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

Primary Purpose

Healthy Volunteers

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986205

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring Healthy participants, Healthy subjects

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

PPD Austin Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

BMS-986205 intact tablet orally then crushed tablet orally

BMS-986205 crushed tablet orally, then intact tablet orally

BMS-986205 intact tablet orally then suspension via NG tube

BMS-986205 suspension via NG tube then intact tablet orally

Arm Description

Single, 100 mg dose

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Incidence of non-serious Adverse Events (AEs).

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

Incidence of Serious Adverse Events (SAEs).

Safety and tolerability as measured by incidence of SAEs.

Number of participants with clinical laboratory abnormalities.

Number of participants with vital sign abnormalities.

Number of participants with electrocardiogram (ECG) abnormalities.

Full Information

NCT ID

NCT03362411

First Posted

November 30, 2017

Last Updated

February 22, 2018

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03362411

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

November 9, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers

Keywords

Healthy participants, Healthy subjects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-986205 intact tablet orally then crushed tablet orally

Arm Type

Experimental

Arm Description

Single, 100 mg dose

Arm Title

BMS-986205 crushed tablet orally, then intact tablet orally

Arm Type

Experimental

Arm Description

Single, 100 mg dose

Arm Title

BMS-986205 intact tablet orally then suspension via NG tube

Arm Type

Experimental

Arm Description

Single, 100 mg dose

Arm Title

BMS-986205 suspension via NG tube then intact tablet orally

Arm Type

Experimental

Arm Description

Single, 100 mg dose

Intervention Type

Drug

Intervention Name(s)

BMS-986205

Intervention Description

Single 100 mg dose on Day 1 and Day 15

Primary Outcome Measure Information:

Title

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.

Description

Measured by plasma concentration.

Time Frame

Up to 22 days

Title

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.

Description

Measured by plasma concentration.

Time Frame

Up to 22 days

Title

Description

Measured by plasma concentration.

Time Frame

Up to 22 days

Title

Description

Measured by plasma concentration.

Time Frame

Up to 22 days

Secondary Outcome Measure Information:

Title

Incidence of non-serious Adverse Events (AEs).

Description

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

Time Frame

Up to 22 days

Title

Incidence of Serious Adverse Events (SAEs).

Description

Safety and tolerability as measured by incidence of SAEs.

Time Frame

Up to 22 days

Title

Number of participants with clinical laboratory abnormalities.

Time Frame

Up to 22 days

Title

Number of participants with vital sign abnormalities.

Time Frame

Up to 22 days

Title

Number of participants with electrocardiogram (ECG) abnormalities.

Time Frame

Up to 22 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

PPD Austin Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.fda.gov/Safety/Recalls/

Description

FDA Safety Alerts and Recalls

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