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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316756
• Other study ID #: B7991001
• Secondary ID: 2014-004394-17
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2014
• Last updated: June 8, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• PF-06648671
Experimental Pfizer compound which will be dosed as oral suspension
• Placebo
Placebo which will be given as oral suspension

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with AEs and SAEs	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	0-6 weeks	Yes
Primary	Supine vital sign measurement	Measurement of blood pressure and pulse rate	0-6 weeks	Yes
Primary	Electrocardiogram (ECG)	Measurement of standard 12-lead ECG, single or triplicate	0-6 weeks	Yes
Primary	Number of participants with lab test values of potential clinical importance	Pre-defined criteria were established for each lab test to identify potential clinical importance	0-6 weeks	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax)		0-72 hours post dose	No
Secondary	Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)		0-72 hours post dose	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)		0-72 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0-72 hours post dose	No
Secondary	Plasma Decay Half-life (t1/2)		0-72 hours post dose	No
Secondary	Apparent Oral Clearance (CL/F)		0-72 hours post dose	No
Secondary	Apparent Volume of Distribution (Vz/F)		0-72 hours post dose	No
Secondary	Plasma Cmax ratio under fed vs fasted conditions		0-72 hours post dose	No
Secondary	Plasma AUClast ratio under fed vs fasted condition		0-72 hours post dose	No
Secondary	Plasma AUCinf ratio under fed vs fasted conditions		0-72 hours post dose	No
Secondary	Plasma Abeta42 Maximum change from baseline		0-72 hours post dose	No
Secondary	Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)		0-72 hours post dose	No
Secondary	Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)		0-72 hours post-dose	No
Secondary	Plasma Abeta40 Maximum change from baseline		0-72 hours post dose	No
Secondary	Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)		0-72 hours post dose	No
Secondary	Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)		0-72 hours post-dose	No