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

Heptares Therapeutics

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: HTL0009936 modified release; Drug: HTL0009936 immediate release

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02710188

9936-104

2015-004921-16 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

HTL0009936 modified release (MR) Formulation

Experimental group

Description:

Intervention: 5 different modified release formulations of HTL0009936, as a single dose

Treatment:

Drug: HTL0009936 modified release

HTL00009936 immediate release (IR) fasted

Active Comparator group

Description:

Intervention: 1 immediate release formulation of HTL0009936, as a single dose in the fasted state

Treatment:

Drug: HTL0009936 immediate release