NCT02840279

A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Tetra Discovery Partners · Industry
• Sex: All
• Age: 25 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled, multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic profile of BPN14770 in healthy young and elderly male and female subjects and to provide a preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects.

Detailed description

Objectives: 1. To evaluate the safety and tolerability profile of multiple oral ascending dose levels of BPN14770 in healthy young and elderly subjects. 2. To characterize the plasma pharmacokinetic profile of BPN14770 following oral administration in healthy young and elderly subjects. 3. To provide preliminary assessment of the cognitive effect of BPN14770 in healthy elderly subjects.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2016-07-21
• Last updated: 2017-01-18

Locations

1 site across 1 country: United States