Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | November 2014 |
A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor Open, Placebo Controlled, Single Ascending Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-04958242 Following Oral Dose Capsules in Healthy Subjects
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a
number of single ascending doses in healthy volunteers
number of single ascending doses in healthy volunteers
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 >55 kg
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.
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