Healthy SubjectsPhase 1NCT02316756
A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects
A Phase 1 study testing PF-06648671 in people with Healthy Subjects, run by Pfizer at 1 site in Belgium.
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. 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
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Mar 2015
- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Subjects
- Being tested
- PF-06648671, Placebo
- Keywords
- Phase 1, Single-Dose Escalation, Double Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, PF-06648671, Plasma Abeta
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
PlaceboDrug
Placebo which will be given as oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses Cohort 1 | Experimental | subjects receive 3 active doses and one placebo Receives: Drug: PF-06648671; Drug: Placebo |
| Single Ascending Doses Cohort 2 | Experimental | subjects receive 3 doses and one placebo Receives: Drug: PF-06648671; Drug: Placebo |
| Cohort 3 | Experimental | optional cohort Receives: Drug: PF-06648671; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-6 weeks
Supine vital sign measurement
Measurement of blood pressure and pulse rate
Measured: 0-6 weeks
Electrocardiogram (ECG)
Measurement of standard 12-lead ECG, single or triplicate
Measured: 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
Measured: 0-6 weeks
Secondary outcomes (16)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0-72 hours post dose
Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)
Measured: 0-72 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Measured: 0-72 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0-72 hours post dose
Plasma Decay Half-life (t1/2)
Measured: 0-72 hours post dose
Apparent Oral Clearance (CL/F)
Measured: 0-72 hours post dose
Apparent Volume of Distribution (Vz/F)
Measured: 0-72 hours post dose
Plasma Cmax ratio under fed vs fasted conditions
Measured: 0-72 hours post dose
Plasma AUClast ratio under fed vs fasted condition
Measured: 0-72 hours post dose
Plasma AUCinf ratio under fed vs fasted conditions
Measured: 0-72 hours post dose
Plasma Abeta42 Maximum change from baseline
Measured: 0-72 hours post dose
Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)
Measured: 0-72 hours post dose
Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)
Measured: 0-72 hours post-dose
Plasma Abeta40 Maximum change from baseline
Measured: 0-72 hours post dose
Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)
Measured: 0-72 hours post dose
Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)
Measured: 0-72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, PfizerLaure Mendes da Costa, MD, Principal investigator, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316756
- Sponsor's protocol ID
- B7991001
- Other IDs
- 2014-004394-17, 2014
- Status last verified
- Jun 2015
- First submitted
- 10 Dec 2014
- Last updated
- 9 Jun 2015
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02316756
- Acronym / sponsor ID
- B7991001
- Conditions
- Healthy Subjects
- Keywords
- Phase 1, Single-Dose Escalation, Double Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, PF-06648671, Plasma Abeta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses Cohort 1 | Experimental | Drug: PF-06648671, Drug: Placebosubjects receive 3 active doses and one placebo |
| Single Ascending Doses Cohort 2 | Experimental | Drug: PF-06648671, Drug: Placebosubjects receive 3 doses and one placebo |
| Cohort 3 | Experimental | Drug: PF-06648671, Drug: Placebooptional cohort |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06648671Experimental Pfizer compound which will be dosed as oral suspension | Drug | Cohort 3, Single Ascending Doses Cohort 1, Single Ascending Doses Cohort 2 |
| PlaceboPlacebo which will be given as oral suspension | Drug | Cohort 3, Single Ascending Doses Cohort 1, Single Ascending Doses Cohort 2 |
Primary outcome
Number of participants with AEs and SAEs
Time frame: 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
Time frame: 0-6 weeks
Measurement of blood pressure and pulse rate
Electrocardiogram (ECG)
Time frame: 0-6 weeks
Measurement of standard 12-lead ECG, single or triplicate
Number of participants with lab test values of potential clinical importance
Time frame: 0-6 weeks
Pre-defined criteria were established for each lab test to identify potential clinical importance
16 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-72 hours post dose
Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)
Time frame: 0-72 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: 0-72 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-72 hours post dose
Plasma Decay Half-life (t1/2)
Time frame: 0-72 hours post dose
Apparent Oral Clearance (CL/F)
Time frame: 0-72 hours post dose
Apparent Volume of Distribution (Vz/F)
Time frame: 0-72 hours post dose
Plasma Cmax ratio under fed vs fasted conditions
Time frame: 0-72 hours post dose
Plasma AUClast ratio under fed vs fasted condition
Time frame: 0-72 hours post dose
Plasma AUCinf ratio under fed vs fasted conditions
Time frame: 0-72 hours post dose
Plasma Abeta42 Maximum change from baseline
Time frame: 0-72 hours post dose
Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)
Time frame: 0-72 hours post dose
Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)
Time frame: 0-72 hours post-dose
Plasma Abeta40 Maximum change from baseline
Time frame: 0-72 hours post dose
Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)
Time frame: 0-72 hours post dose
Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)
Time frame: 0-72 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Derived from this study: PubMed 31314925Ahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Laure Mendes da Costa, MD principal investigator
Pfizer
1 site in 1 country: see every site and its status.
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 1 site in Belgium.
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 3 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 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. 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?
Number of participants with AEs and SAEs (time frame: 0-6 weeks). The study lists 4 primary outcomes in all. 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 NCT02316756, 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 9 Jun 2015.