A Multiple Ascending Dose Study of COR388
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03418688|
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: COR388 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease|
|Actual Study Start Date :||March 6, 2018|
|Actual Primary Completion Date :||October 15, 2018|
|Actual Study Completion Date :||October 15, 2018|
Active Comparator: COR388
Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.
COR388 administered for 10 or 28 days.
Other Name: COR388 HCl
Placebo Comparator: Placebo
Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.
Placebo administered for 10 or 28 days.
- AUC [ Time Frame: Day 1 and Day 10 ]Area under the concentration-time curve
- Cmax [ Time Frame: Day 1 and Day 10 ]Maximum observed drug concentration during a dosing interval
- Tmax [ Time Frame: Day 1 and Day 10 ]Time to Cmax
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): NCT03418688
|United States, California|
|Pacific Research Network|
|San Diego, California, United States, 92103|
|United States, Florida|
|Orlando, Florida, United States, 32806|
|United States, Ohio|
|Medpace Clinical Pharmacology Unit|
|Cincinnati, Ohio, United States, 45227|