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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004394-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Doses Cohort 1 | Experimental | subjects receive 3 active doses and one placebo |
|
| Single Ascending Doses Cohort 2 | Experimental | subjects receive 3 doses and one placebo |
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| Cohort 3 | Experimental | optional cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06648671 | Drug | Experimental Pfizer compound which will be dosed as oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Laure Mendes da Costa, MD | Pfizer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31314925 | Derived | 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. |
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| Placebo | Drug | Placebo which will be given as oral suspension |
|
| 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 |
| Apparent Oral Clearance (CL/F) | 0-72 hours post dose |
| Apparent Volume of Distribution (Vz/F) | 0-72 hours post dose |
| Plasma Cmax ratio under fed vs fasted conditions | 0-72 hours post dose |
| Plasma AUClast ratio under fed vs fasted condition | 0-72 hours post dose |
| Plasma AUCinf ratio under fed vs fasted conditions | 0-72 hours post dose |
| Plasma Abeta42 Maximum change from baseline | 0-72 hours post dose |
| Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC) | 0-72 hours post dose |
| Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax) | 0-72 hours post-dose |
| Plasma Abeta40 Maximum change from baseline | 0-72 hours post dose |
| Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC) | 0-72 hours post dose |
| Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax) | 0-72 hours post-dose |