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A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers

Last updated on August 9, 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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy persons, male or female.

- For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.

- For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.

- Body Mass Index (BMI) of 18 to 35; and a total body weight >50 kg (110 lbs)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with clinically significant medical conditions.

- Women of non-child bearing potential.

- Subjects with a known medical history of hearing loss/disability or nonarteritic
ischemic optic neuropathy.

- A positive urine drug screen.

NCT01161069
Pfizer
Completed
A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers

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A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Toleration, Pharmacokinetics Of PF-03049423 In Healthy Young Adult Volunteers And Healthy Elderly Volunteers
The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.
The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: PF-03049423
    PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers
  • Drug: PF-03049423
    PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers
  • Drug: PF-03049423
    PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers
  • Drug: PF-03049423
    PF-03049423 in oral solution, 3 mg, given once daily for 7 days, then 6 mg given once daily for 7 days; healthy elderly adult volunteers
  • Drug: PF-03049423
    PF-03049423 in oral solution, 5 mg, given once daily for 7 days, then 10 mg given once daily for 7 days; healthy elderly adult volunteers
  • Drug: Placebo
    Placebo in oral solution, given once daily for 14 days
  • Active Comparator: PF-03049423
    Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers
    Interventions:
    • Drug: PF-03049423
    • Drug: PF-03049423
    • Drug: PF-03049423
    • Drug: PF-03049423
    • Drug: PF-03049423
  • Placebo Comparator: Drug
    Placebo in oral solution, given once daily for 14 days
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy persons, male or female.
  • For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.
  • For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.
  • Body Mass Index (BMI) of 18 to 35; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Subjects with clinically significant medical conditions.
  • Women of non-child bearing potential.
  • Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy.
  • A positive urine drug screen.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01161069
A9541002
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 2011

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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