NCT02407353

Brief Summary

This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 25, 2015

Last Update Submit

March 21, 2016

Conditions

Healthy Subjects

Keywords

Phase 1Double blindPlacebo-ControlledParallel DesignCSF Aβ ConcentrationsPF-06648671

Outcome Measures

Primary Outcomes (1)

  • CSF Aβ40 and Aβ42 concentration at maximum change from baseline

    0-36 hours postdose

Secondary Outcomes (17)

  • Number of participants with AEs and SAEs

    0-2 weeks

  • supine vital sign

    0-2 weeks

  • Electrocardiogram (ECG)

    0-2 weeks

  • Maximum Observed Plasma Concentration (Cmax)

    0-72 hours postdose

  • Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)

    0-72 hours postdose

  • +12 more secondary outcomes

Study Arms (4)

PF-06648671 High dose group

EXPERIMENTAL

subjects receive a single oral dose of PF-06648671 at 300 mg

Drug: PF-06648671

PF-06648671 Low dose group

EXPERIMENTAL

Subjects receive a single oral dose of PF-06648671 lower than 300 mg dose

Drug: PF-06648671

Placebo group

PLACEBO COMPARATOR

Subjects receive matching placebo

Drug: Placebo

PF-06648671 Low dose group (2)

EXPERIMENTAL

Optional arm. Subjects receive a single oral dose of PF-06648671 at second lower dose if 300 mg dose is not repeated in cohort 2

Drug: PF-06648671

Interventions

PF-06648671DRUG

Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses

PF-06648671 High dose groupPF-06648671 Low dose groupPF-06648671 Low dose group (2)
PlaceboDRUG

Placebo which will be dosed as oral suspension, single doses to match PF-06648671

Placebo group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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)
  • Subjects with a history of significant active bleeding, coagulation disorder or clinically significant finding on prothrombin time/ partial thromboplastin time/International Normalized Ratio (PT/PTT/INR) at Screening
  • Subjects with lower spinal malformations (on physical examination), local spinal infection, or other abnormalities that would exclude puncture (LP)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

California Clinical Trials Medical Group, Inc.

Glendale, California, 91206, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Related Publications (1)

  • Ahn JE, Carrieri C, Dela Cruz F, Fullerton T, Hajos-Korcsok E, He P, Kantaridis C, Leurent C, Liu R, Mancuso J, Mendes da Costa L, Qiu R. Pharmacokinetic and Pharmacodynamic Effects of a gamma-Secretase Modulator, PF-06648671, on CSF Amyloid-beta Peptides in Randomized Phase I Studies. Clin Pharmacol Ther. 2020 Jan;107(1):211-220. doi: 10.1002/cpt.1570. Epub 2019 Sep 11.

    PMID: 31314925DERIVED

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 2, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

US(2)