LFBB: Semagacestat thorough QTc study

• Research type

  Research Study

• Full title

  Protocol H6L-MC-LFBB: A Placebo- and Positive-Controlled Study of the Electrophysiological Effects on the QT Interval after Single Doses of Semagacestat in Healthy Subjects

• IRAS ID

  47532

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2009-016825-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to determine if semagacestat increases the QT interval on the ECGs of healthy volunteers. The QT interval is a measurement taken from an ECG which represents the point in the cardiac cycle where the heart is refilling between beats. It is important to assess a drug??s effect on the QT interval as patients with increased QT intervals may be at increased risk of developing abnormal heart rhythms (in particular a rhythm called Ventricular Tachycardia) which can be life threatening. Up to approximately 64 subjects will be enrolled. Each subject will take part in four study periods. Each study period will last approximately 4 days. There will be a washout period of 5 - 8 days between dosing at each treatment period. In each study period subjects will receive one of the following treatment regimens: - A single oral dose of semagacestat (280mg) - A single oral dose of semagacestat (140mg) - A single oral dose of placebo - A single oral dose of moxifloxacin (400mg) Each subject will receive each treatment once. Treatment allocation will be randomly assigned in order to reduce bias. At each treatment period, intensive ECG sampling will be performed on Day 1. Changes in ECG parameters from baseline will be calculated at each treatment period and compared. Post study safety assessment will be performed prior to check out at the fourth treatment period. Subjects will be followed up by telephone approximately 5-8 days after the last dose to ensure they remain in good health.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/4

• Date of REC Opinion

  30 Mar 2010

• REC opinion

  Further Information Favourable Opinion