An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy Participants

NCT03312426 | Completed Phase 1 FDA Drug

• 1 other identifier: CA017-053
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of a light meal and a high-fat meal on the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants. Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions will be assessed.

Conditions

Healthy Volunteers

Keywords

Cancer; Tumor; Healthy Participants; Healthy Subjects; Neoplasm

Outcome Measures

Primary Outcomes (4)

• Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.

  Measured by plasma concentration.

  Up to 21 days

• Area under the plasma concentration-time curve from time zero to 168 hours (AUC[0-168]) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.

  Measured by plasma concentration.

  Up to 21 days

• Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal.

  Measured by plasma concentration.

  Up to 21 days

• AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal.

  Measured by plasma concentration.

  Up to 21 days

Secondary Outcomes (4)

• Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) following administration of single, 100 mg tablet of BMS-986205 under fasting conditions, with a light meal or with a high-fat meal.

  Day 1 up to Day 22

• Results of clinical laboratory tests

  Up to 22 days

• Results of vital sign measurements

  Up to 22 days

• Results of electrocardiogram (ECG)

  Up to 22 days

Study Arms (4)

BMS-986205 under fasted conditions then with high-fat meal.

EXPERIMENTAL

Single, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a high-fat meal (Day 15).

Drug: BMS-986205

BMS-986205 with high-fat meal then under fasted conditions.

EXPERIMENTAL

Single, 100 mg dose of BMS-986205 with a high-fat meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15).

Drug: BMS-986205

BMS-986205 under fasted conditions then with light meal.

EXPERIMENTAL

Single, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a light meal (Day 15).

Drug: BMS-986205

BMS-986205 with light meal then under fasted conditions.

EXPERIMENTAL

Single, 100 mg dose of BMS-986205 with a light meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15).

Drug: BMS-986205

Interventions

BMS-986205 DRUG

Single dose, 100 mg administered at Day 1 and at Day 15.

BMS-986205 under fasted conditions then with high-fat meal.; BMS-986205 under fasted conditions then with light meal.; BMS-986205 with high-fat meal then under fasted conditions.; BMS-986205 with light meal then under fasted conditions.

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

Conditions

Neoplasms

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 17, 2017
• Study Start: October 9, 2017
• Primary Completion: November 22, 2017
• Study Completion: November 22, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

US (1)