Study of safety and effects of HTL0009936 in healthy subjects

  • Research type

    Research Study

  • Full title

    A Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of HTL0009936 in Healthy Subjects

  • IRAS ID

    138245

  • Contact name

    Annelize Koch

  • Contact email

    Annelize.Koch@parexel.com

  • Sponsor organisation

    Heptares Therapeutics

  • Eudract number

    2013-002307-34

  • ISRCTN Number

    not provided

  • Research summary

    The new medicine tested in this study is a compound called HTL0009936. Heptares is developing HTL0009936 for treating Alzheimer’s disease. Alzheimer’s disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks. Alzheimer’s disease is the most common cause of dementia among older people.

    The study will be performed in 4 different main parts, with each part having its own specific purpose. The main purpose of the study is to determine HTL0009936 safety and tolerability. The study will also look at the levels of HTL0009936 in the blood, urine and cerebrospinal fluid.

    HTL0009936 will be administered as single and multiple ascending doses, with and without food as a single dose, and with scopolamine to determine the effects of HTL0009936 on cognitive functions.

    This study will recruit healthy males between the ages of 18 and 55 years, and also healthy elderly males and females aged 65 years and older.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    13/LO/1575

  • Date of REC Opinion

    18 Nov 2013

  • REC opinion

    Further Information Favourable Opinion