NCT03031574

A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects

A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Suven Life Sciences Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.

Detailed description

The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.

Conditions

• Cognitive Disorder

Interventions

Type	Name	Description
DRUG	SUVN-D4010	Tablets

Timeline

• Start date: 2017-01-23
• Primary completion: 2017-08-29
• Completion: 2017-09-07
• First posted: 2017-01-25
• Last updated: 2017-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study