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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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

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Detailed Description

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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

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HTL0009936 modified release (MR) Formulation

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

Group Type EXPERIMENTAL

HTL0009936 modified release

Intervention Type DRUG

HTL0009936 modified release

HTL00009936 immediate release (IR) fasted

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

Group Type ACTIVE_COMPARATOR

HTL0009936 immediate release

Intervention Type DRUG

HTL0009936 immediate release

Interventions

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HTL0009936 modified release

Intervention Type DRUG

HTL0009936 immediate release

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes