A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled First-in-human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06648671 After Administration Of Single Ascending Doses To Fasted And Fed Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-06648671
- Conditions
- Healthy Subjects
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of participants with AEs and SAEs
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and/or female subjects of non childbearing potential
- •BMI of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)
- •Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drg allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing);
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
- •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 judgement of the investigator, would make the subject inappropriate for entry into this study.
Arms & Interventions
Single Ascending Doses Cohort 1
subjects receive 3 active doses and one placebo
Intervention: PF-06648671
Single Ascending Doses Cohort 1
subjects receive 3 active doses and one placebo
Intervention: Placebo
Single Ascending Doses Cohort 2
subjects receive 3 doses and one placebo
Intervention: PF-06648671
Single Ascending Doses Cohort 2
subjects receive 3 doses and one placebo
Intervention: Placebo
Cohort 3
optional cohort
Intervention: PF-06648671
Cohort 3
optional cohort
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with AEs and SAEs
Time Frame: 0-6 weeks
Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurences of an AE within a category will be counted once within the category
Supine vital sign measurement
Time Frame: 0-6 weeks
Measurement of blood pressure and pulse rate
Electrocardiogram (ECG)
Time Frame: 0-6 weeks
Measurement of standard 12-lead ECG, single or triplicate
Number of participants with lab test values of potential clinical importance
Time Frame: 0-6 weeks
Pre-defined criteria were established for each lab test to identify potential clinical importance
Secondary Outcomes
- Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)(0-72 hours post-dose)
- Plasma Abeta40 Maximum change from baseline(0-72 hours post dose)
- Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)(0-72 hours post dose)
- Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)(0-72 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax)(0-72 hours post dose)
- Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)(0-72 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)(0-72 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0-72 hours post dose)
- Plasma Decay Half-life (t1/2)(0-72 hours post dose)
- Apparent Oral Clearance (CL/F)(0-72 hours post dose)
- Apparent Volume of Distribution (Vz/F)(0-72 hours post dose)
- Plasma Cmax ratio under fed vs fasted conditions(0-72 hours post dose)
- Plasma AUClast ratio under fed vs fasted condition(0-72 hours post dose)
- Plasma AUCinf ratio under fed vs fasted conditions(0-72 hours post dose)
- Plasma Abeta42 Maximum change from baseline(0-72 hours post dose)
- Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)(0-72 hours post dose)