PK Study to Evaluate Safety and Tolerability of Revamilast

• Research type

  Research Study

• Full title

  Revamilast - A Phase I, Randomized, Double Blind, Placebo Controlled, Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects

• IRAS ID

  63693

• Contact name

  Ashley Brooks

• Sponsor organisation

  Glenmark Pharmacuticals

• Eudract number

  2010-022807-22

• Research summary

  This is a randomized, placebo-controlled, multiple, ascending, oral-dose study of revamilast (GRC 4039) in health male and female volunteers. 16 healthy subjects in each of two cohorts will receive doses of revamilast at dose levels of 6mg (Group A), 8mg (Group B) or placebo. Each subject will take place in a single treatment period where they will receive once daily doses for 21 Days. Each dose will be administered as up to 4 tablets. Subjects will check out of the unit 2 days after the last dose has been administered. The subjects will then attend the unit for 5 outpatient visits where blood samples and urine will be collected. In addition, at the last outpatient visit a thorough safety assessment including physical examination will be performed. In each group there will be 4 male and 4 female subjects aged 18 to 45 and 4 male and 4 female subjects aged 45 to 65. There will be four subjects on placebo in each group (one from each age and gender group). Dosing of Group 2 will only take place once safety data up to Day 14 and PK data up to Day 7 from Group 1 have been reviewed. While on study safety and tolerability will be monitored by adverse event questioning, physical examination, vital signs measurements, 12-lead ECGs, continuous 3-lead cardiac monitoring (telemetry; for 6 hours post dose on Days 1 and 21), clinical laboratory evaluations and testing stool for the presence of blood (“faecal occult blood testing”). The levels of drug in the blood and urine will be regularly measured to determine how much of the drug is getting into the blood and urine and how long it is staying there.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/22

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion