NCT02710188

Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation

A Phase 1 Relative Bioavailability Study in Healthy CYP2D6 Intermediate (IM) and Extensive Metaboliser (EM) Subjects, Designed to Evaluate the Pharmacokinetic (PK) Profile of HTL0009936 Following Single Dose Administration of Modified Release (MR) Prototype Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Nxera Pharma UK Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.

Detailed description

The aim of the study is to develop a modified release oral tablet formulation that maintains plasma concentrations within the target therapeutic range, and is safe and tolerable.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	HTL0009936 modified release	HTL0009936 modified release
DRUG	HTL0009936 immediate release	HTL0009936 immediate release

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-03-16
• Last updated: 2016-10-18

Locations

1 site across 1 country: United Kingdom