Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers

NCT02725112

Last updated date
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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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

1. Healthy female subjects and/or male subjects who, at the time of screening, are 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 electrocardiogram (ECG) or clinical laboratory tests. A 1:1 ratio of men to women is desirable, but it will not be considered a protocol deviation if this is not met.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

3. Evidence of a personally signed and dated informed consent document.

4. 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


1. 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 the time of dosing).


2. History of febrile illness within 5 days prior to the first dose of study
investigational product.


3. Subjects with an estimated CLcr <60 mL/min derived using the method of Crockcroft and
Gault.1


4. Any condition possibly affecting drug absorption.


5. A positive urine drug screen.


6. Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day.


7. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
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.


8. Treatment with an investigational drug within 30 days or 5 half lives preceding the
first dose of study investigational product (whichever is longer).


9. Screening supine blood pressure >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure is >= 140 mm Hg
(systolic) or >= 90 mm Hg (diastolic), the blood pressure should be repeated 2 more
times and the average of the 3 blood pressure values should be used to determine the
subject's eligibility.


10. Screening supine 12 lead ECG demonstrating QTc (time from ECG Q wave to the end of the
T wave corresponding to electrical systole [QT] corrected for the heart rate) >450
msec or a QRS interval (time from ECG Q wave to the end of the S wave corresponding to
ventricle depolarization) >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec,
the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values
should be used to determine the subject's eligibility.


11. Pregnant female subjects; breastfeeding female subjects; male subjects with partners
currently pregnant; male subjects able to father children and female subjects of
childbearing potential who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product.


12. 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.investigational product. Herbal supplements must be
discontinued at least 28 days prior to the first dose of study
medicationinvestigational product. As an exception, acetaminophen/paracetamol may be
used at doses of greater than 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.


13. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.


14. History of sensitivity to pregabalin, gabapentin, or other alpha2 delta ligands.


15. History of sensitivity to heparin or heparin induced thrombocytopenia.


16. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.


17. Previous participation in a study involving pregabalin.


18. Subjects who are investigational site staff members directly involved in the study,
their family members, site staff members otherwise supervised by the investigator, or
subjects who are Pfizer employees directly involved in the study.


19. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Open-label, Single-dose, 6-period Study To Investigate The Effect Of In Vitro Dissolution Rate On The In Vivo Bioavailability Of Extended Release Formulations Of Pregabalin In Healthy Volunteers
Brief Summary This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be replaced at the Sponsor's discretion. Screening activities will be completed within approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6 treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6 periods with subjects receiving single doses of pregabalin ER 330 mg target release rate tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments will be administered following a 600- 750 calorie, 30% fat evening meal.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Pregabalin ER
    A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.
  • Drug: Pregabalin ER
    B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.
  • Drug: Pregabalin ER
    C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.
  • Drug: Pregabalin ER
    D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.
  • Drug: Pregabalin ER
    E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.
  • Drug: Pregabalin ER
    F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.
Study Arms  ICMJE
  • Experimental: Pregabalin ER- Target Release 330mg
    A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.
    Intervention: Drug: Pregabalin ER
  • Experimental: Pregabalin ER - Slow Release 330mg
    B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.
    Intervention: Drug: Pregabalin ER
  • Experimental: Pregabalin ER - Fast Release 330mg
    C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.
    Intervention: Drug: Pregabalin ER
  • Experimental: Pregabalin IR - 300mg
    D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.
    Intervention: Drug: Pregabalin ER
  • Experimental: Pregabalin ER - Target Release 82.5mg
    E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.
    Intervention: Drug: Pregabalin ER
  • Experimental: Pregabalin ER - Aberrant Fast 330mg
    F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.
    Intervention: Drug: Pregabalin ER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2016)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
24
Actual Study Completion Date  ICMJE June 17, 2016
Actual Primary Completion Date May 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy female subjects and/or male subjects who, at the time of screening, are 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 electrocardiogram (ECG) or clinical laboratory tests. A 1:1 ratio of men to women is desirable, but it will not be considered a protocol deviation if this is not met.
  2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  3. Evidence of a personally signed and dated informed consent document.
  4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. 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 the time of dosing).
  2. History of febrile illness within 5 days prior to the first dose of study investigational product.
  3. Subjects with an estimated CLcr <60 mL/min derived using the method of Crockcroft and Gault.1
  4. Any condition possibly affecting drug absorption.
  5. A positive urine drug screen.
  6. Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  7. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 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.
  8. Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study investigational product (whichever is longer).
  9. Screening supine blood pressure >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure is >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), the blood pressure should be repeated 2 more times and the average of the 3 blood pressure values should be used to determine the subject's eligibility.
  10. Screening supine 12 lead ECG demonstrating QTc (time from ECG Q wave to the end of the T wave corresponding to electrical systole [QT] corrected for the heart rate) >450 msec or a QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
  11. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  12. 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.investigational product. Herbal supplements must be discontinued at least 28 days prior to the first dose of study medicationinvestigational product. As an exception, acetaminophen/paracetamol may be used at doses of greater than 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.
  13. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  14. History of sensitivity to pregabalin, gabapentin, or other alpha2 delta ligands.
  15. History of sensitivity to heparin or heparin induced thrombocytopenia.
  16. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  17. Previous participation in a study involving pregabalin.
  18. Subjects who are investigational site staff members directly involved in the study, their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the study.
  19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02725112
Other Study ID Numbers  ICMJE A0081309
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP