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Safety and Tolerability Study of Multiple Doses of PF-06305591

Last updated on May 11, 2018

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
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subjects of non childbearing potential, between the ages of 21
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

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).

- Any condition possibly affecting drug absorption (eg, gastrectomy).

NCT01776619
Pfizer
Completed
Safety and Tolerability Study of Multiple Doses of PF-06305591

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Safety and Tolerability Study of Multiple Doses of PF-06305591
A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects
Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06305591
    14 day repeated 20mg BID doses
  • Drug: Placebo
    14 day repeated BID doses
  • Drug: PF-06305591
    14 day repeated 80mg BID doses
  • Drug: PF-06305591
    14 day repeated 40mg BID doses
  • Drug: PF-06305591
    14 day repeated BID doses
  • Drug: PF-06305591
    relative bioavailability tablet vs. solution and food effect at 50mg dose
  • Experimental: Multiple Dose: Cohort 1
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Multiple Dose: Cohort 2
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Multiple Dose: Cohort 3
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Multiple Dose: Cohort 4
    Intervention: Drug: PF-06305591
  • Experimental: Relative Bioavilability: Cohort 1
    Intervention: Drug: PF-06305591
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
November 2013
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects of non childbearing potential, between the ages of 21 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

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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01776619
B5281002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 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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