NCT01959594
Completed
Phase 1
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
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- 3 mg PF-06412562
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
Intervention: 3 mg PF-06412562
Cohort 2
Intervention: 10 mg PF-06412562
Cohort 3
Intervention: 25 mg PF-06412562
Optional Cohort 4
Intervention: PF-06412562 TBD mg
Optional Cohort 5
Intervention: PF-06412562 TBD mg
Outcomes
Primary Outcomes
Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,
Time Frame: 0-15 days
Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS.
Time Frame: 0-15 days
CogState at followup
Time Frame: 22-25 days
Study Sites (1)
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