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

Sponsor:	Inhibitex
Information provided by (Responsible Party):	Inhibitex
ClinicalTrials.gov Identifier:	NCT01159808

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: INX-08189 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title:	A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects

Further study details as provided by Inhibitex:

Primary Outcome Measures:

Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects [ Time Frame: periodically over 14 days ] [ Designated as safety issue: Yes ]
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.
Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects [ Time Frame: periodically over 14 days ] [ Designated as safety issue: Yes ]
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.
Assess the effect of a high fat meal on the PK parameters [ Time Frame: periodically over 14 days ] [ Designated as safety issue: Yes ]
The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated

Enrollment:	42
Study Start Date:	May 2010
Study Completion Date:	October 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INX-08189	Drug: INX-08189 3, 25 and 100 mg capsules; oral administration, single dose
Placebo Comparator: Placebo	Drug: Placebo matching placebo capsules, oral administration, single dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159808

Sponsors and Collaborators

Inhibitex

Investigators

Study Director:

Brian Boehlecke, MD, MSPH

More Information

No publications provided

Responsible Party:	Inhibitex
ClinicalTrials.gov Identifier:	NCT01159808 History of Changes
Other Study ID Numbers:	INH-189-001
Study First Received:	July 1, 2010
Last Updated:	November 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inhibitex:

Safety and Pharmacokinetics

ClinicalTrials.gov processed this record on February 09, 2012