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

NCT03362411 | Completed Phase 1 FDA Drug

• 1 other identifier: CA017-070
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy participants; Healthy subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

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

  Up to 22 days

• Incidence of Serious Adverse Events (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

Study Arms (4)

BMS-986205 intact tablet orally then crushed tablet orally

EXPERIMENTAL

Single, 100 mg dose

Drug: BMS-986205

BMS-986205 crushed tablet orally, then intact tablet orally

EXPERIMENTAL

Single, 100 mg dose

Drug: BMS-986205

BMS-986205 intact tablet orally then suspension via NG tube

EXPERIMENTAL

Single, 100 mg dose

Drug: BMS-986205

BMS-986205 suspension via NG tube then intact tablet orally

EXPERIMENTAL

Single, 100 mg dose

Drug: BMS-986205

Interventions

BMS-986205 DRUG

Single 100 mg dose on Day 1 and Day 15

BMS-986205 crushed tablet orally, then intact tablet orally; BMS-986205 intact tablet orally then crushed tablet orally; BMS-986205 intact tablet orally then suspension via NG tube; BMS-986205 suspension via NG tube then intact tablet orally

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Austin Clinic

Austin, Texas, 78744, United States

Location

Related Links

• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Interventions

linrodostat

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 5, 2017
• Study Start: November 9, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)