A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: PF-06648671; Drug: Placebo

• Registration Number: NCT02316756
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single Ascending Doses Cohort 2	Placebo	subjects receive 3 doses and one placebo
Single Ascending Doses Cohort 1	PF-06648671	subjects receive 3 active doses and one placebo
Single Ascending Doses Cohort 1	Placebo	subjects receive 3 active doses and one placebo
Single Ascending Doses Cohort 2	PF-06648671	subjects receive 3 doses and one placebo
Cohort 3	PF-06648671	optional cohort
Cohort 3	Placebo	optional cohort

Primary Outcome Measures

Name	Time	Method
Number of participants with lab test values of potential clinical importance	0-6 weeks	Pre-defined criteria were established for each lab test to identify potential clinical importance
Number of participants with AEs and SAEs	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	0-6 weeks	Measurement of blood pressure and pulse rate
Electrocardiogram (ECG)	0-6 weeks	Measurement of standard 12-lead ECG, single or triplicate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium