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A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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 female subjects of non-childbearing potential and/or male subjects 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 pulse rate measurement, 12-lead ECG and clinical
laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; 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

- 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).

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

NCT01959594
Pfizer
Completed
A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

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A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects
This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: 3 mg PF-06412562
    oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days
  • Drug: 10 mg PF-06412562
    oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days
  • Drug: 25 mg PF-06412562
    oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days
  • Drug: PF-06412562 TBD mg
    oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts
  • Experimental: Cohort 1
    Intervention: Drug: 3 mg PF-06412562
  • Experimental: Cohort 2
    Intervention: Drug: 10 mg PF-06412562
  • Experimental: Cohort 3
    Intervention: Drug: 25 mg PF-06412562
  • Experimental: Optional Cohort 4
    Intervention: Drug: PF-06412562 TBD mg
  • Experimental: Optional Cohort 5
    Intervention: Drug: PF-06412562 TBD mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy female subjects of non-childbearing potential and/or male subjects 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 pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);

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).
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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
 
 
NCT01959594
B7441002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

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

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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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