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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362411
• Other study ID #: CA017-070
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2017
• Last updated: February 22, 2018
• Start date: November 9, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Healthy Volunteers

Intervention

Drug:
• BMS-986205
Single 100 mg dose on Day 1 and Day 15

Locations

Country	Name	City	State
United States	PPD Austin Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form