Effect of Tasisulam on CYP2C9-Mediated Metabolism of Tolbutamide

• Research type

  Research Study

• Full title

  The Effect of Tasisulam on the CYP2C9-Mediated Metabolism of Tolbutamide: A Pharmacokinetic Interaction Study in Cancer Patients with Advanced and/or Metastatic Solid Tumors or Lymphoma

• IRAS ID

  40289

• Contact name

  Christopher Twelves

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2009-016563-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The primary objective is to assess the effect of tasisulam on CYP2C9-mediated metabolism of tolbutamide when given concurrently. This will be achieved using pharmacokinetic analyses of tolbutamide when dosed alone (period 1), then when tasisulam is dosed 4h post tolbutamide dosing (period 2), and then when tasisulam is dosed 72h post tolbutamide dosing (period 3) (note: 72h dosing interval may change depending on interim analysis results from period 1 PK). Subjects will be assessed for eligibility during a screening period and prior to dosing in each study period. Monitoring for adverse events and other safety procedures will be carried out throughout the study. Other objectives of the study are to assess the safety and tolerability of tasisulam and tolbutamide in each study period and to evaluate whether dosing of tolbutamide after tasisulam results in attenuation of any effects observed in concurrent dosing on CYP2C9-mediated metabolism of tolbutamide. Group 1 will complete Periods 1, 2 and 3; group 2 will complete Period 1 and 3 only. 20 Subjects are required to complete period 3 of the study (out of approximately no more than 50 randomised). Participation in the initial phase of the study (periods 1 to 3) will be no more than 13 weeks. Upon completion of periods 1 to 3 (group 1) or periods 1 and 3 (group 2), if eligible, subjects will be invited to participate in an extended use phase of the study where they will receive a single dose of tasisulam in 4 week cycles. Subjects will remain in the extended use phase until their disease progresses or they withdraw consent or are withdrawn by the investigator.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/19

• Date of REC Opinion

  20 Apr 2010

• REC opinion

  Further Information Favourable Opinion