ABOUT THIS STUDY
- Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- History of febrile illness within 5 days prior to the first dose of study medication.
- Subjects with an estimated creatinine clearance (CLcr) <60 mL/min derived using the
method of Cockcroft and Gault1.
- Any condition possibly affecting drug absorption (eg, gastrectomy, irritable bowel
- A positive urine drug screen.
- Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
- 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If
QTc exceeds 450 msec or QRS exceeds 120 msec, the ECG should be repeated two more
times and the average of the three QTc or QRS values should be used to determine the
- Pregnant or nursing females; females of childbearing potential who are unwilling or
unable to use an acceptable method of contraception as outlined in this protocol from
at least 14 days (for nonhormonal methods) or approximately 3 months (for hormonal
contraception) prior to the first dose of study medication and for 28 days after the
last dose of study medication.
- Use of prescription (other than oral, transdermal, intrauterine, implanted, or
injected contraceptives or hormone replacement therapy) or nonprescription drugs and
dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the
first dose of study medication. Herbal supplements must be discontinued at least 28
days prior to the first dose of study medication. As an exception,
acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of
non-prescription medications that are not believed to affect subject safety or the
overall results of the study may be permitted on a case by case basis following
approval by the sponsor.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- History of sensitivity to pregabalin, gabapentin, or other alpha 2 delta ligands.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this
- Previous participation in a study involving pregabalin.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
- Subjects with active suicidal ideation or suicidal behavior within 1 year prior to
Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity
Rating Scale) or active ideation identified at Screening or on Day 1.
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