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

NCT01159808 | Completed Phase 1 DMC

• 2 other identifiers: AI472-001INH-189-001
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Keywords

Safety and Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects

  Safety will be evaluated on the basis of adverse event (AE) incidence, changes in serum chemistry and hematology values, urinalysis results, and changes in vital signs and in electrocardiogram (ECG) findings.

  periodically over 14 days

• Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects

  Including a determination of maximum observed plasma concentration (Cmax), time at which the maximum plasma concentration was observed (Tmax), time at which concentrations are first measurable in the plasma (Tlag), area under the plasma concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-last) and elimination half-life (T 1/2) after single ascending oral doses.

  periodically over 14 days

• Assess the effect of a high fat meal on the PK parameters

  The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated

  periodically over 14 days

Study Arms (2)

INX-08189

EXPERIMENTAL

Drug: INX-08189

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

INX-08189 DRUG

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

INX-08189

Placebo DRUG

matching placebo capsules, oral administration, single dose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

MeSH Terms

Interventions

BMS-986094

Study Officials

• Brian Boehlecke, MD, MSPH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 9, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 22, 2012

Record last verified: 2012-06