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

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

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.

Inclusion Criteria:

• Healthy males & females
• Aged 18 to 65 years
• Body mass index of 18.0 to 35.0 kg/m2
• CYP2D6 (intermediate or extensive metabolizer)

Exclusion Criteria:

• Subjects with a resting heart rate (HR) >90 bpm, and/or systolic blood pressure (BP) >150 mmHg, and/or diastolic BP >90 mmHg
• Subjects with QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms (males) or >470 ms (females)
• Personal or family history of long QT syndrome or sudden death
• Subjects who are CYP2D6 (poor or ultra-rapid metabolizer)