Effect of Activated Charcoal & dose time on absorption of LY2624803

• Research type

  Research Study

• Full title

  Evaluation of the Impact of Activated Charcoal and Time of Dose on the Absorption of LY2624803 in Healthy Subjects

• IRAS ID

  63852

• Contact name

  Ashley Brooks

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-021725-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Eli Lilly & Company is developing a new drug for use in insomnia. LY2624803 has been designed to target mechanisms that ??let you sleep? rather than depress the entire brain to ??make you sleep.? LY2624803 has specific histamine and serotonin receptor antagonism and does not produce other unwanted side effects and it also penetrates into the brain well. Studies have been completed in more than 150 healthy male (~75%) and female (~25%) subjects. LY2624803 doses of 0.1 mg to 10 mg have been studied so far. In completed clinical pharmacology studies, LY2624803 was generally safe and well tolerated across all doses studied (from 0.1 mg to 10 mg). There was no evidence of rebound insomnia or adverse reactions suggesting a drug-discontinuation or withdrawal syndrome. The present study is designed to determine the effect of activated charcoal on the absorption of LY2624803. The study will be an open label study over 3 periods. In each period 3 different treatments will be given. All subjects must crossover to complete all 3 treatments over three periods. The order in which subjects will receive the treatments will be determined randomly (by chance, like flipping a coin). In each study period, subjects will be required to remain at the CRU for at least 48 hours post dose. There will be a washout period of at least 7 days between dosing occasions. The 3 different treatments are as follows:Treatment A: LY2624803 administered alone at approximately 0800 hours following an overnight fast.Treatment B: LY2624803 administered at approximately 0800 hours following an overnight fast, followed1 hour later by a single oral dose of 1 g/kg activated charcoal, mixed with caffeine-free diet cola.Treatment C: LY2624803 administered alone at approximately 2200 hours following 4 hour fast.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/28

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion