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A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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

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

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

- Subjects must be CYP2D6 extensive metabolizers, ultrarapid metabolizers or
intermediate metabolizers, as predicted by CYP2D6 genotyping.

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).

- 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 450 msec, 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.

- 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 hormone replacement therapy must be discontinued 28 days prior to the
first dose of study medication. Depo Provera® must be discontinued at least 6 months
prior to the first dose of study medication. As an exception,
acetaminophen/paracetamol may be used at doses of prescription medications that are not believed to affect subject safety or the overall
results the study may be permitted on a case by case basis.

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

- History of sensitivity to heparin or heparin induced thrombocytopenia.

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

NCT00999817
Pfizer
Completed
A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers

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Similar Trials

A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers
An Open Label Phase 1, Randomized Cross Over Trial To Estimate The Effect Of PF- 00299804 On The Pharmacokinetics Of Dextromethorphan In Healthy Volunteers
A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: reference [dextromethorphan]
    single 30 mg oral dose
  • Drug: test [PF-00299804 + dextromethorphan]
    single 45 mg oral dose of PF-00299804 and a single 30 mg oral dose of dextromethorphan
  • A
    Single 30 mg dose of dextromethorphan
    Intervention: Drug: reference [dextromethorphan]
  • Experimental: B
    Single 45 mg dose of PF-00299804 plus a single 30 mg oral dose of dextromethorphan
    Intervention: Drug: test [PF-00299804 + dextromethorphan]
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female of non childbearing potential 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 and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Subjects must be CYP2D6 extensive metabolizers, ultrarapid metabolizers or intermediate metabolizers, as predicted by CYP2D6 genotyping.

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).
  • 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 450 msec, 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.
  • 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 hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo Provera® must be discontinued at least 6 months 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 the study may be permitted on a case by case basis.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00999817
A7471039
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

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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[email protected]



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