A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted
A Phase 1, Randomized, Open Label, Single Dose, 5-treatment, 5- Period Crossover Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release Pregabalin Tablet Formulations Administered Following an Evening Meal and the Immediate Release Formulation Administered Fasted
1 other identifier
interventional
16
1 country
1
Brief Summary
This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a 330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th period to to estimate and compare the % of dose absorbed versus time profile for the three CR prototype tablets and the CR reference tablet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJanuary 22, 2021
September 1, 2018
1 month
September 27, 2011
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Area under plasma concentration-time curve from time zero extrapolated to infinite time (AUClast)
predose to 48hr post dose
Area under plasma concentration-time profile from time zero to time of last quantifiable concentration (AUCinf)
predose to 48hr post dose
Maximum observed concentration within dosing interval (Cmax)
predose to 48hr post dose
Time for Cmax Tmax
predose to 48hr post dose
Terminal half-life (t1/2)
predose to 48hr post dose
Safety endpoints will be evaluated by comparing the incidence and severity of AEs for each of the formulations evaluated
predose to 48hr post dose
Study Arms (4)
Sequence 1
EXPERIMENTALSequence 2
EXPERIMENTALSequence 3
EXPERIMENTALSequence 4
EXPERIMENTALInterventions
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
300 mg IR capsule administered in the evening in the fasted state.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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 syndrome).
- 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 medication.
- 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 subject's eligibility.
- 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 protocol.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2011
First Posted
September 29, 2011
Study Start
March 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
January 22, 2021
Record last verified: 2018-09