None listed
Conditions
Brief summary
Nucleus Network Limited. The primary purpose of this study is to determine if BMS-817399 can be safely administered to human beings at dose ranges that may provide clinical benefit to patients of rheumatoid arthritis. The study has no formal research hypothesis to be statistically tested. The study will be carried out in normal healthy volunteers under close observation to determine BMS-817399 dose ranges that are safe and tolerable in human beings. Initially, BMS-817399 will be given as a single dose by mouth, with doses increasing till the highest tolerated dose that is also safe is determined. Following this, BMS-817399 will be given as more than one dose daily by mouth for a period of fourteen days, with doses increasing in amount till the highest tolerated dose that is also safe is determined. To know the amount of BMS-817399 that has entered into the body, blood will be drawn for testing. Other test will also be done to see if BMS-817399 is safe and has the expected effects in the body. During the period of dosing and testing, the patient will be confined to the clinic for close observation. Taking part in this study will not provide any medical benefit to the subjects.
Interventions
Ascending single and multiple oral doses of BMS-817399, a chemokine receptor 1 antagonist administered to healthy subjects.
The effect of food (high-fat meal) will also be studied.
In the single ascending dose part (SAD; Part A), 8 subjects/panel, will receive single oral dose of the test medication (or placebo in 3:1 ratio) in a double blinded manner as follows:
Panel 1: 20 mg capsule
Panel 2: 80 mg capsule
Panel 3: 200 mg capsule under fast in Period 1 and 200 mg capsule after a high fat meal
Ascending single and multiple oral doses of BMS-817399, a chemokine receptor 1 antagonist administered to healthy subjects. The effect of food (high-fat meal) will also be studied. In the single ascending dose part (SAD; Part A), 8 subjects/panel, will receive single oral dose of the test medication (or placebo in 3:1 ratio) in a double blinded manner as follows: Panel 1: 20 mg capsule Panel 2: 80 mg capsule Panel 3: 200 mg capsule under fast in Period 1 and 200 mg capsule after a high fat meal* in Period 2 (to study food effect) Panel 4: 400 mg capsule in Period 1 and 400 mg oral suspension in Period 2 Panel 5: 800 mg capsule Panel 6: 1600 mg oral suspension Panel 7: 2000 mg oral suspension. *High fat meal contain 54.6 mg fat, 82.3 mg carbohydrate and 32.1 gram of protein. The high fat meal will be served within 30 minutes prior to dosing and the subject must ingest the meal completely within this time period. The duration of each period in Part A is 5 days postdose, with a single dose administered on Day 1. No subject from Part A of the study will participate in Part B of the study. In the multiple ascending dose part (MAD; Part B), 8 subjects/panel, will receive the test medication (or placebo in 3:1 ratio) orally 2 times a day (every 12 hours) for 13 days and a single dose on Day 14 in a double blinded manner as follows: Panel 1: 40 mg capsule Panel 2: 100 mg capsule Panel 3: 200 mg capsule Panel 4: 400 mg capsule Panel 5: 800 mg capsule Panel 6: 1000 mg capsule The duration of each panel in Part B will be 17 days with dosing up to Day 14.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects (men and women) having Body Mass Index (BMI) between 18 and 32 kg/m2 Women must not be of childbearing potential (i.e., who are postmenopausal or surgically sterile).
Exclusion criteria
Any significant acute or chronic medical illness. Subjects at risk for tuberculosis (TB). Evidence of organ dysfunction or any clinically significant deviation from normal. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) greater than 1.25 x upper normal limit (UNL) at screening.
Outcome results
None listed