Effect of Activated Charcoal on Absorption of LY2140023

• Research type

  Research Study

• Full title

  A Study to Evaluate the Impact of Activated Charcoal on the Absorption of LY2140023 in Healthy Subjects

• IRAS ID

  102154

• Contact name

  Ashley Brooks

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2012-001323-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study drug, LY2140023 is converted by the body to the active ingredient LY404039. Administration of the study drug has been developed to enhance the amount of active ingredient in the blood stream. The study drug is being developed for the treatment of schizophrenia. There is a risk of drug overdose with any medicinal agent when a large amount of the medication is ingested. Activated charcoal is widely used in the management of poisoning and drug overdose. The reduction in absorption and the increase in apparent clearance of drugs and poisons with co-administration of activated charcoal have been observed for many substances. This study is designed to determine the effect of activated charcoal on the level of study drug LY2140023 and the breakdown product/active ingredient LY404039 in healthy subjects by measuring levels in blood. The study is an open label, randomized, 2 period crossover study. Each subject will be exposed to an 80 mg dose of LY2140023 on 2 different occasions with a washout interval of at least 3 days between dosing occasions. The duration of the study from admission to the Clinical Research Unit (CRU) to the follow-up visit may be up to 16 days (excluding screening). Up to 18 subjects may be enrolled to ensure that 12 subjects complete the study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0244

• Date of REC Opinion

  24 May 2012

• REC opinion

  Further Information Favourable Opinion