Open-label, PK and Safety Study in Mild-to-moderate Alzheimer's Disease Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03748706|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: PTI-125||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a, Open-label, Multiple Dose, Safety, Pharmacokinetic and Biomarker Study of PTl-125 in Mild-to-moderate Alzheimer's Disease Patients|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
PTI-125 100 mg oral tablets administered twice daily (BID)
Oral 100 mg tablet
- Maximum Plasma Concentration (Cmax) [ Time Frame: Study Days 1, 2, 28 and 29 ]Blood draws will be done to evaluate levels of PTI-125 in the plasma using non-compartmental methods in WinNonlin.
- Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Study Days 1, 2, 28 and 29 ]Levels of PTI-125 will be assessed to determine how long it takes to reach the Cmax
- Last Quantifiable Plasma Concentration (Clast) [ Time Frame: Study Day 1, 2, 28 and 29 ]Levels of PTI-125 will be assessed to determine the last time point where PTI-125 can be detected.
- Time to Last Quantifiable Plasma Concentration (Tlast) [ Time Frame: Study Days 1, 2, 28 and 29 ]Levels of PTI-125 will be assessed to determine the elapsed time to where PTI-125 can last be detected in the plasma.
- Area Under the Curve (AUC) [ Time Frame: Study Days 1, 2, 28 and 29 ]AUC for PTI-125 plasma concentration from time zero to the last quantifiable plasma concentration.
- Minimum Plasma Concentration (Cmin) [ Time Frame: Study Days 7 and 14 ]Assessment of the lowest plasma concentration of PTI-125
- PTI-125DX (biomarker) [ Time Frame: Study Days 1, 7, 14 and 29 ]Blood samples will be tested for the companion dignostic/biomarker for Alzheimer's disease.
- Biomarker assay [ Time Frame: Day 28 ]A CSF sample collection will be performed for Aβ/tau, YKL40 and other potential CSF biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748706
|Contact: Michael R Marsman, PharmDfirstname.lastname@example.org|
|United States, Texas|
|Insite Clinical Research||Recruiting|
|DeSoto, Texas, United States, 75115|
|Contact: Brian Green, MBA 972-331-6898 email@example.com|
|Clinical Trials of Texas||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Nathan Cortez, MS 210-949-0122 ext 108 firstname.lastname@example.org|