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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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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) 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.

- 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
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.

- 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.

NCT01443169
Pfizer
Completed
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

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Sequence 1 - Treatment A: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 1 - Treatment B: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 1 - Treatment C:Controlled Release Pregabalin
    330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 1 - Treatment D: Controlled Release Pregabalin
    330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 1 - Treatment E: Immediate Release Pregabalin
    300 mg IR capsule administered in the evening in the fasted state.
  • Drug: Sequence 2 - Treatment B: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 2 - Treatment D: Controlled Release Pregabalin
    330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 2 - Treatment A: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 2 - Treatment C: Controlled Release Pregabalin
    330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 2 - Treatment E: Immediate Release Pregabalin
    300 mg IR capsule administered in the evening in the fasted state.
  • Drug: Sequence 3 - Treatment C: Controlled Release Pregabalin
    330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 3 - Treatment A: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 3 - Treatment D: Controlled Release Pregabalin
    330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 3 - Treatment B: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 3 - Treatment E: Immediate Release Pregabalin
    300 mg IR capsule administered in the evening in the fasted state.
  • Drug: Sequence 4 - Treatment D: Controlled Release Pregabalin
    330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 4 - Treatment C: Controlled Release Pregabalin
    330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 4 - Treatment B: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 4 - Treatment A: Controlled Release Pregabalin
    330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
  • Drug: Sequence 4 - Treatment E: Immediate Release Pregabalin
    300 mg IR capsule administered in the evening in the fasted state.
  • Experimental: Sequence 1
    Interventions:
    • Drug: Sequence 1 - Treatment A: Controlled Release Pregabalin
    • Drug: Sequence 1 - Treatment B: Controlled Release Pregabalin
    • Drug: Sequence 1 - Treatment C:Controlled Release Pregabalin
    • Drug: Sequence 1 - Treatment D: Controlled Release Pregabalin
    • Drug: Sequence 1 - Treatment E: Immediate Release Pregabalin
  • Experimental: Sequence 2
    Interventions:
    • Drug: Sequence 2 - Treatment B: Controlled Release Pregabalin
    • Drug: Sequence 2 - Treatment D: Controlled Release Pregabalin
    • Drug: Sequence 2 - Treatment A: Controlled Release Pregabalin
    • Drug: Sequence 2 - Treatment C: Controlled Release Pregabalin
    • Drug: Sequence 2 - Treatment E: Immediate Release Pregabalin
  • Experimental: Sequence 3
    Interventions:
    • Drug: Sequence 3 - Treatment C: Controlled Release Pregabalin
    • Drug: Sequence 3 - Treatment A: Controlled Release Pregabalin
    • Drug: Sequence 3 - Treatment D: Controlled Release Pregabalin
    • Drug: Sequence 3 - Treatment B: Controlled Release Pregabalin
    • Drug: Sequence 3 - Treatment E: Immediate Release Pregabalin
  • Experimental: Sequence 4
    Interventions:
    • Drug: Sequence 4 - Treatment D: Controlled Release Pregabalin
    • Drug: Sequence 4 - Treatment C: Controlled Release Pregabalin
    • Drug: Sequence 4 - Treatment B: Controlled Release Pregabalin
    • Drug: Sequence 4 - Treatment A: Controlled Release Pregabalin
    • Drug: Sequence 4 - Treatment E: Immediate Release Pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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 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.
  • 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01443169
A0081286
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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