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A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers

Last updated on May 10, 2018

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
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

- For all cohorts, healthy male and/or female subjects of nonchildbearing 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 heart rate measurement, 12 lead ECG and
clinical laboratory tests).

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).

- Pregnant or nursing women; women of childbearing potential. Female subjects must be of
non childbearing potential defined by a history of surgical sterilization (eg,
hysterectomy or bilateral oophorectomy) or post menopausal status (complete absence of
menses for at least two consecutive years) and elevated FSH concentration in women
between 45 and 55.

NCT01091272
Pfizer
Completed
A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers

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A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers
A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04995274 After Administration Of Single Oral Doses To Healthy Adult Subjects
The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.
The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: PF-04995274
    Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
  • Drug: PF-04995274
    Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
  • Drug: PF-04995274
    Planned single PO 120mg and 210mg doses of PF-04995274
  • Drug: PF-04995274
    single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data
  • Experimental: Cohort 1
    Single dose 3 period interleaved cross-over with placebo substitution
    Intervention: Drug: PF-04995274
  • Experimental: Cohort 2
    Single dose 4 period interleaved cross-over, placebo substitution, with food effect
    Intervention: Drug: PF-04995274
  • Experimental: Cohort 3
    Single dose 4 period cross-over, placebo insertion, with food effect
    Intervention: Drug: PF-04995274
  • Experimental: Optional Cohort 4
    Single dose 3 period cross-over with placebo substitution
    Intervention: Drug: PF-04995274
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • For all cohorts, healthy male and/or female subjects of nonchildbearing 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 heart rate measurement, 12 lead ECG and clinical laboratory tests).

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).
  • Pregnant or nursing women; women of childbearing potential. Female subjects must be of non childbearing potential defined by a history of surgical sterilization (eg, hysterectomy or bilateral oophorectomy) or post menopausal status (complete absence of menses for at least two consecutive years) and elevated FSH concentration in women between 45 and 55.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01091272
B1661001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 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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Contact

[email protected]



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