NCT02316756

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

December 10, 2014

Last Update Submit

June 8, 2015

Conditions

Healthy Subjects

Keywords

Phase 1, Single-Dose Escalation, Double Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, PF-06648671, Plasma Abeta

Outcome Measures

Primary Outcomes (4)

  • 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

  • Supine vital sign measurement

    Measurement of blood pressure and pulse rate

    0-6 weeks

  • Electrocardiogram (ECG)

    Measurement of standard 12-lead ECG, single or triplicate

    0-6 weeks

  • 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

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (3)

Single Ascending Doses Cohort 1

EXPERIMENTAL

subjects receive 3 active doses and one placebo

Drug: PF-06648671Drug: Placebo

Single Ascending Doses Cohort 2

EXPERIMENTAL

subjects receive 3 doses and one placebo

Drug: PF-06648671Drug: Placebo

Cohort 3

EXPERIMENTAL

optional cohort

Drug: PF-06648671Drug: Placebo

Interventions

PF-06648671DRUG

Experimental Pfizer compound which will be dosed as oral suspension

Cohort 3Single Ascending Doses Cohort 1Single Ascending Doses Cohort 2
PlaceboDRUG

Placebo which will be given as oral suspension

Cohort 3Single Ascending Doses Cohort 1Single Ascending Doses Cohort 2

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

  • Laure Mendes da Costa, MD

    Pfizer

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 15, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

BE(1)