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To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers

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NCT01045863

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

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.

- 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.

- Signs or symptoms of adrenal insufficiency.

- Ocular lens (eye) abnormalities.

NCT01045863
Pfizer
Terminated
To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers

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To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers
A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-03382792 After Administration Of Single Oral Doses To Healthy Adult Subjects
The purpose of this study is to evaluate safety and tolerability after a single administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and biological activity.
Evaluate the safety, tolerability, plasma concentrations of PF-03382792 and other biological activity following a single dose of PF-03382792. Three ascending single doses of PF-03382792 were administered in this study (0.05 mg, 0.15mg and 0.5 mg). The decision to terminate the study was made on June 4, 2010 due to safety findings and limitations regarding the levels of the metabolite projected for doses above 0.5 mg.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: PF-03382792 Cohort 1
    First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
  • Drug: PF-03382792 Cohort 2
    Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
  • Drug: PF-03382792
    Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.
  • Drug: Food Effect cohort
    Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion.
  • Drug: CSF cohort
    Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.
  • Experimental: PART A: Ascending Cohorts
    Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)
    Interventions:
    • Drug: PF-03382792 Cohort 1
    • Drug: PF-03382792 Cohort 2
    • Drug: PF-03382792
  • Experimental: PART B: Food effect
    Food effect on PF-03382792 PK
    Intervention: Drug: Food Effect cohort
  • Experimental: PART C: CSF Cohort
    Optional CSF Cohort
    Intervention: Drug: CSF cohort
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
June 2010
June 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.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • 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.
  • Signs or symptoms of adrenal insufficiency.
  • Ocular lens (eye) abnormalities.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01045863
B1651001
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 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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