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Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-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

- healthy young subjects

- aged 18-55

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 the time of dosing).

- Pregnant or nursing females; females of childbearing potential.

NCT01747941
Pfizer
Completed
Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

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Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06305591
    single dose, solution
  • Drug: Placebo
    matching placebo
  • Experimental: Cohort 1
    Single ascending oral doses in fasted conditions
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Cohort 2
    Single ascending oral doses in fasted conditions
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Cohort 3
    Single ascending oral doses in fed conditions
    Interventions:
    • Drug: PF-06305591
    • 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
30
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy young subjects
  • aged 18-55

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 the time of dosing).
  • Pregnant or nursing females; females of childbearing potential.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01747941
B5281001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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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