AzTrials
AzTrials

Healthy SubjectsPhase 1NCT02407353

A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)

A Phase 1 study testing PF-06648671 in people with Healthy Subjects, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
PF-06648671
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
2 sitesUnited States
Study dates
Oct 2015to Mar 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • California Clinical Trials Medical Group, Inc.

    Glendale, California, 91206

  • Glendale Adventist Medical Center

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase 1 Investigator-and-subject Blind, Randomized, Placebo Controlled, Parallel Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Oral Doses Of Pf-06648671 On Aβ Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology

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.

Read the detailed description

This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled, parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma) pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of 300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more subjects are required) and/or 1-2 lower doses

Being tested
PF-06648671, Placebo
Keywords
Phase 1, Double blind, Placebo-Controlled, Parallel Design, CSF Aβ Concentrations, PF-06648671

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06648671Drug

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

  • PlaceboDrug

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

Study groups in NCT02407353
Study groupRoleWhat they receive
PF-06648671 High dose groupExperimentalsubjects receive a single oral dose of PF-06648671 at 300 mg
Receives: Drug: PF-06648671
PF-06648671 Low dose groupExperimentalSubjects receive a single oral dose of PF-06648671 lower than 300 mg dose
Receives: Drug: PF-06648671
Placebo groupPlacebo comparatorSubjects receive matching placebo
Receives: Drug: Placebo
PF-06648671 Low dose group (2)ExperimentalOptional arm. Subjects receive a single oral dose of PF-06648671 at second lower dose if 300 mg dose is not repeated in cohort 2
Receives: Drug: PF-06648671

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CSF Aβ40 and Aβ42 concentration at maximum change from baseline

    Measured: 0-36 hours postdose

Secondary outcomes (17)

  1. 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 occurrence of an AE within a category will be counted once within the category

    Measured: 0-2 weeks

  2. supine vital sign

    Measurement of supine vital signs

    Measured: 0-2 weeks

  3. Electrocardiogram (ECG)

    Measurement of standard 12-lead ECG (single)

    Measured: 0-2 weeks

  4. Maximum Observed Plasma Concentration (Cmax)

    Measured: 0-72 hours postdose

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

    Measured: 0-72 hours postdose

  6. Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)

    Measured: 0-72 hours postdose

  7. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: 0-72 hours postdose

  8. Plasma Decay Half-life (t1/2)

    Measured: 0-72 hours postdose

  9. Apparent Oral Clearance (CL/F)

    Measured: 0-72 hours postdose

  10. Apparent Volume of Distribution (Vz/F))

    Measured: 0-72 hours postdose

  11. Maximum Observed CSF Concentration (CSF Cmax)

    Measured: 0-36 hours postdose

  12. Area Under the Curve from Time Zero to Last Quantifiable Concentration in CSF (CSF AUClast)

    Measured: 0-36 hours postdose

  13. Area Under the Curve From Time Zero to Extrapolated Infinite Time in CSF (CSF AUCinf)

    Measured: 0-36 hours postdose

  14. CSF Decay Half-life (CSF t1/2)

    Measured: 0-36 hours postdose

  15. Plasma Aβ40, Aβ42 and Aβtotal

    Plasma Aβ40, Aβ42 and Aβtotal if possible

    Measured: 0-72 hours postdose

  16. CSF Aβ37, Aβ38 and Aβtotal Concentration

    Measured: 0-36 hours postdose

  17. 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

    Measured: 0-2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407353
Sponsor's protocol ID
B7991003
Status last verified
Mar 2016
First submitted
25 Mar 2015
Last updated
22 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31314925

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06648671 in people with Healthy Subjects, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CSF Aβ40 and Aβ42 concentration at maximum change from baseline (time frame: 0-36 hours postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02407353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in