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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Heptares Therapeutics Limited
• Collaborator: Quotient Clinical

Criteria

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)