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A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Pain, Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects (of non childbearing potential) 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 and clinical
laboratory tests).

- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg
(110 lbs).

- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

- Subjects who are willing and able to comply with 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 (including hyperlipidemia), pancreatic,
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.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for men (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 at screening. If QTc exceeds 450msec, the ECG
should be repeated two more times and the average of the three QTc values should be
used to determine the subject's eligibility.

- Females of childbearing potential.

- Use of prescription 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 and hormonal replacement therapy must be discontinued 28 days prior to the
first dose of study medication. As an exception, ibuprofen may be used at doses of up
to 1800 mg/day with food. Limited use of non-prescription medications that are not
believed to affect subject safety or overall results of the study may be permitted on
a case -by-case basis following approval by the sponsor.

- Unwillingness to refrain from consumption of grapefruit or grapefruit/pomelo
containing products within 7 days prior to the first dose of study medication until
the completion of the follow-up visit.

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

- Unwilling or unable to comply with the Lifestyle guidelines described in this
protocol.

- Subject is the Investigator or sub-Investigator. research assistant, pharmacist, study
coordinator, other staff, or a relative of study personnel directly involved with the
conduct of the study.

- 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.

- The use of marijuana (or other illicit drugs) within 30 days of randomization.

NCT00836082
Pfizer
Completed
A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers

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A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers
A Phase 1, Double-Blind (Sponsor Open), Randomised, Placebo-Controlled, Parallel Group, Oral Multiple-Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04457845 In Healthy Volunteers
To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14 days will be safe and well tolerated in healthy volunteers. To determine the effect on food on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg and 8mg.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Acute Pain
  • Chronic Pain
  • Drug: PF-04457845, FAAH inhibitor
    Oral solution of 0.5mg given once daily for 14 days.
  • Drug: PF-04457845, FAAH inhibitor
    Oral solution of 1mg given once daily for 14 days.
  • Drug: PF-04457845, FAAH inhibitor
    Oral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days.
  • Drug: PF-04457845, FAAH inhibitor
    A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase
  • Drug: PF-04457845, FAAH inhibitor
    Oral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days.
  • Experimental: Cohort 1 (N=10)
    Placebo-controlled, escalating multiple doses of 0.5mg per day for 14 days.
    Intervention: Drug: PF-04457845, FAAH inhibitor
  • Experimental: Cohort 2 (N=10)
    Placebo-controlled, escalating multiple doses of 1mg per day for 14 days.
    Intervention: Drug: PF-04457845, FAAH inhibitor
  • Experimental: Cohort 3 (N=10)
    Placebo-controlled, escalating multiple doses of 4mg per day for 14 days.
    Interventions:
    • Drug: PF-04457845, FAAH inhibitor
    • Drug: PF-04457845, FAAH inhibitor
  • Experimental: Cohort 4 (N=10)
    Placebo-controlled, escalating multiple doses of 8mg per day for 14 days.
    Interventions:
    • Drug: PF-04457845, FAAH inhibitor
    • Drug: PF-04457845, FAAH inhibitor
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects (of non childbearing potential) 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 and clinical laboratory tests).
  • Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hyperlipidemia), pancreatic, 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.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (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 at screening. If QTc exceeds 450msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
  • Females of childbearing potential.
  • Use of prescription 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 and hormonal replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, ibuprofen may be used at doses of up to 1800 mg/day with food. Limited use of non-prescription medications that are not believed to affect subject safety or overall results of the study may be permitted on a case -by-case basis following approval by the sponsor.
  • Unwillingness to refrain from consumption of grapefruit or grapefruit/pomelo containing products within 7 days prior to the first dose of study medication until the completion of the follow-up visit.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
  • Subject is the Investigator or sub-Investigator. research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study.
  • 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.
  • The use of marijuana (or other illicit drugs) within 30 days of randomization.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00836082
B0541002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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