A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects
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|ClinicalTrials.gov Identifier: NCT02840279|
Recruitment Status : Completed
First Posted : July 21, 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 multiple oral ascending dose levels of BPN14770 in healthy young and elderly subjects.
- To characterize the plasma pharmacokinetic profile of BPN14770 following oral administration in healthy young and elderly subjects.
- To provide preliminary assessment of the cognitive effect of BPN14770 in healthy elderly subjects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Examine the Safety, Tolerability, Pharmacokinetic, and Preliminary Cognitive Profile of BPN14770 in Healthy Young and Elderly Male and Female Subjects|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||December 2016|
An 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
An oral dose of placebo matching BPN14770
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 weeks ]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 to Twelve Hours [AUC0-12] [ Time Frame: 2 weeks ]
- Area Under the Concentration Time Curve from Zero to 12 Hours, Corrected for Dose [AUC12/D] [ Time Frame: 2 weeks ]
- ISLT-D [ Time Frame: 2 weeks ]International Shopping List Test words recalled at 24 hours
- GMLT-D [ Time Frame: 2 weeks ]Groton Maze Learning Test errors at 24 hours
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): NCT02840279
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|Study Chair:||Scott Reines, MD, PhD||Tetra Discovery Partners|