A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects

NCT ID: NCT01159808

Last Updated: 2012-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-10-31

Brief Summary

The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:

• To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
• To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
• To assess the food effect on the PK of a single oral dose of INX-08189

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: TRIPLE

Study Groups

INX-08189

Group Type: EXPERIMENTAL

INX-08189

Intervention Type: DRUG

3, 25 and 100 mg capsules; oral administration, single dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo capsules, oral administration, single dose

Interventions

INX-08189

3, 25 and 100 mg capsules; oral administration, single dose

Intervention Type: DRUG

Placebo

matching placebo capsules, oral administration, single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

2. Age 18 to 65 years, inclusive

3. Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)

4. No clinically significant abnormalities on ECG (QTcB interval must be < 450 ms)

5. Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive

6. Negative urine drug screen at screening and on Study Day -1

7. Negative serum βHCG pregnancy test at screening and on Study Day -1 (for all women)

8. Hepatitis B surface antigen, hepatitis C antibody, and HIV antibody negative

9. Agreement to practice a barrier method of birth control plus the use of a spermicide throughout the study period by both male and female subjects (oral contraceptives are not permitted)

10. Able to complete all study visits

11. Signed informed consent form (ICF)

Exclusion Criteria

1. Any active medical problem for which the subject is being evaluated and/or treated

2. Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) < 50 mL/min/1.73 m2

3. Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing

4. Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)

5. Current lactation or breastfeeding

6. Major surgery within 30 days prior to dosing

7. Receipt of an investigational drug within 30 days prior to dosing

8. Donation of blood or plasma within 30 days prior to dosing

9. Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Boehlecke, MD, MSPH

Role: STUDY_DIRECTOR

Other Identifiers

INH-189-001

Identifier Type: OTHER

Identifier Source: secondary_id

AI472-001

Identifier Type: -

Identifier Source: org_study_id