Effect of tasisulam on CYP2C19 mediated metabolism of omeprazole

• Research type

  Research Study

• Full title

  The Effect of Tasisulam on CYP2C19 -Mediated Metabolism of Omeprazole: A Pharmacokinetic Interaction Study in Cancer Patients with Advanced and/or Metastatic Solid Tumors or Lymphoma

• IRAS ID

  55202

• Contact name

  Christopher Twelves

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-019750-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The primary objective of the study is to assess the effect of tasisulam on CYP2C19- mediated metabolism of omeprazole when given concurrently. This will be assessed by evaluating blood concentrations of omeprazole when dosed alone (Period 1), when omeprazole and tasisulam are given simultaneously (Period 2) and when dosing of omeprazole and tasisulam are staggered (Period 3).Other objectives of the study are to assess the safety and tolerability of tasisulam and omeprazole. Patients will be assessed for eligibility during a screening period and prior to dosing in each study period. Monitoring for adverse events, laboratory safety parameters and dose related toxicities will be carried out throughout the study. A total of 20 patients are required to complete Period 3 of the study. Following preliminary analyses, it will be decided if additional patients will be enrolled into Group 2, to ensure that a total of 20 patients complete Period 3 at the required dose interval. On completion of the study, eligible patients will be invited to participate in an extended phase of the study where they will receive tasisulam in 28-day cycles. Safety bloods will be taken and patients will continue until disease progression or they decide to withdraw or are withdrawn by the Investigator.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/115

• Date of REC Opinion

  26 Nov 2010

• REC opinion

  Further Information Favourable Opinion