BPN14770 Single Ascending Dose Study in Healthy Male and Female Subjects
|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: NCT02648672|
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: BPN14770 Drug: Placebo||Phase 1|
- To evaluate the safety and tolerability profile of single oral ascending dose levels of BPN14770 in healthy subjects.
- To characterize the BPN14770 plasma pharmacokinetic profile following oral administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Single Ascending Dose Study to Examine the Safety, Tolerability, and Pharmacokinetic Profile of BPN14770 in Healthy Male and Female Subjects|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||July 2016|
A single oral dose of BPN14770.
BPN14770 is an investigational new drug being developed for the treatment of Alzheimer's disease and other cognitive disorders. BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D.
Placebo Comparator: Placebo
A single oral dose of placebo matching BPN14770
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 week ]Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG)
- Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] [ Time Frame: 48 hr ]
- Maximum Concentration [Cmax] [ Time Frame: 48 hr ]
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): NCT02648672
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|Study Chair:||Scott Reines, MD, PhD||Tetra Discovery Partners|