Clinical trial NCT01159808: A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
Official title: A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety and Pharmacokinetics
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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


Eligibility criteria: Inclusion Criteria:

1. 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)
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

Primary outcomes:
measure: Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
timeFrame: periodically over 14 days
measure: Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
timeFrame: periodically over 14 days
measure: Assess the effect of a high fat meal on the PK parameters
timeFrame: periodically over 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Brian Boehlecke, MD, MSPH
role: STUDY_DIRECTOR
References: