Status:
COMPLETED
A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- Healthy men and post-menopausal (absence of periods for more than 2 years) surgically sterile, or non-pregnant, non-lactating women using a reliable form of contraception (see Inclusion Criteria 9)
- Age 18 to 65 years, inclusive
- Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)
- No clinically significant abnormalities on ECG (QTcB interval must be \< 450 ms)
- Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive
- Negative urine drug screen at screening and on Study Day -1
- Negative serum βHCG pregnancy test at screening and on Study Day -1 (for all women)
- Hepatitis B surface antigen, hepatitis C antibody, and HIV antibody negative
- 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)
- Able to complete all study visits
- Signed informed consent form (ICF)
Exclusion
- Any active medical problem for which the subject is being evaluated and/or treated
- Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) \< 50 mL/min/1.73 m2
- Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing
- Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)
- Current lactation or breastfeeding
- Major surgery within 30 days prior to dosing
- Receipt of an investigational drug within 30 days prior to dosing
- Donation of blood or plasma within 30 days prior to dosing
- Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01159808
Start Date
May 1 2010
End Date
October 1 2010
Last Update
June 22 2012
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