Not Yet RecruitingPhase 1ACTRN12611001038987

Placebo-Controlled, Single and Multiple Ascending Dose Study of BMS-929075 in Healthy Subjects.

Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-929075 in Healthy Subjects.

Sponsor

Bristol-Myers Squibb Company

Enrollment

96 participants

Start Date

Nov 20, 2011

Study Type

Interventional

Conditions

Hepatitis C

Summary

The purpose of this study is to assess the safety and tolerability of BMS-929075 in healthy subjects.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 49 Yearss

Inclusion Criteria2

Healthy men and women ages 18 to 49
Body Mass Index (BMI) of 18 to 32kg/m2

Exclusion Criteria11

Any significant acute or chronic medical illness, including any:
liver disease with laboratory screening results for ALT, AST or bilirubin > upper limit of normal
gastrointestinal disease within the past 3 months.
Any major surgery, donation of blood or plasma to a blood bank or receipt of a blood transfusion within the past 4 weeks.
Smoking more than 10 cigarettes per day.
Healthy subjects with any of the following ECG findings prior to dosing:
PR>/= 210 msec
QRS>/= 120 msec
QT>/= 500 msec
QTcF>/+ 450 msec
Positive urine screen for drugs of abuse or positive screen for Hepatitis C, Hepatitis B or HIV.

Print for Your Doctor

Interventions

PART A: Eight healthy subjects will be assigned to each of 6 sequential dose treatment groups; each receiving a single oral dose of either 5, 25, 100, 200, 400, a 'potential panel of less than or equal to 800mg' of BMS-929075 or placebo. The exact dose for the 'potential dose panel' will be based upon the safety and pharmacokinetic analysis from the previous dose panels. Based on exposures from these subjects, the subjects given the 200mg dose (treatment group 4) and 400mg dose (treatment group 5) will remain in the clinic for further dosing. Treatment Group 1: subjects receive a single oral dose of 5mg BMS-929075 or placebo. Treatment Group 2: subjects receive a single oral dose of 25mg BMS-929075 or placebo. Treatment Group 3: subjects receive a single oral dose of 100mg BMS-929075 or placebo. Treatment Group 4: subjects receive a single oral dose of 200mg BMS-929075 or placebo, then a second 200mg oral dose of BMS-929075 or placebo with a high fat meal. Treatment Group 5: subjects receive a single oral dose of 400mg BMS-929075 or placebo, then 100mg Ritonavir orally the night of Day 4 and a second 25mg oral dose of BMS-929075 or placebo with 100mg Ritonavir orally on Day 5. Treatment Group 6: subjects receive a single oral dose of less than or equal to 800mg BMS-929075 or placebo. PART B: Eight healthy subjects will be assigned to each of 6 sequential dose treatment groups; each receiving multiple oral doses of either 5, 25, 100, 200, 400, a 'potential panel of less than or equal to 800mg' of BMS-929075 or placebo. The exact dose for the 'potential dose panel' will be based upon the safety and pharmacokinetic analysis from the previous dose panels. Treatment Group 1: subjects assigned to receive oral dose of 5mg BMS-929075 or placebo daily for 14 days. Treatment Group 2: subjects assigned to receive oral dose of 25mg BMS-929075 or placebo daily for 14 days. Treatment Group 3: subjects assigned to receive oral dose of 100mg BMS-929075 or placebo daily for 14 days. Treatment Group 4: subjects assigned to receive oral dose of 200mg BMS-929075 or placebo daily for 14 days. Treatment Group 5: subjects assigned to receive oral dose of 400mg BMS-929075 or placebo daily for 14 days. Treatment Group 6: subjects assigned to receive oral dose of less than or equal to 800mg BMS-929075 or placebo daily for 14 days.