ovance number 8235126: The impact of food and a food supplement on the

• Research type

  Research Study

• Full title

  Impact of Gelucire 44/14 and early assessment of food effect on pharmacokinetics of S42909 after a single oral dose administration in young healthy male volunteers. A mono-centre, open-label, randomised, 4-way cross-over pharmacokinetic study.

• IRAS ID

  66184

• Contact name

  Joseph Chiesa

• Sponsor organisation

  International Centre for Therapeutic Research (UK)

• Eudract number

  2010-022371-58

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  S42909 is a drug being developed for the treatment of leg ulcers caused by venous disease. It is hoped that this drug will inhibit a number of processes that occur in people with venous disease and prevent regular formation. The company developing this drug and funding this study, (known as the Sponsor) is the Institut de Recherches Internationales Servier (I.R.I.S.) and is located in France. S 42909 has been found to be better absorbed by the body when it is combined with a substance called Gelucire, so combinations of S 42909 with and without Gelucire will be tested in this Study. Gelucire is a marketed compound already used with other drugs, including ibuprofen, to increase absorption. The maximum daily oral intake suggested by the manufacturer of Gelucire is 1500 mg day and in this Study the highest daily intake is 1395 mg. In this Study the maximum dose of S 42909 is 105mg with Gelucire and 630mg without Gelucire. Since there were no safety issues in the first in man study at single doses up to 840mg, the dose of 630mg S42909 without Gelucire has been chosen. The formulations to be evaluated are: 1. S 42909/ Gelucire 44/14; 35 mg/ 465 mg per capsule2. S 42909/ Gelucire 44/14; 35 mg/ 215 mg per capsule3 S 42909 105 mg capsules This Study will look at how safe and well-tolerated the Study drug is. The study will also measure how much of the drug gets into the blood stream and how long it takes the body to remove it and what affect the drug has on the body. The study is also intended to make a preliminary assessment of the effect food has on these parameters. A total of 16 male subjects will be enrolled in this study. They will be randomly allocated to 5 treatment groups as shown in Table 1 and rotate through 4 sequential groups as shown in Table 2:Table 1:Treatment A 3 capsules S 42909/ Gelucire 44/14; 35/465 (total dose 105 mg/1395 mg), fasted Treatment B 3 capsules S 42909/ Gelucire 44/14; 35/465 (total dose 105 mg/ 1395 mg)after receiving a High Fat High Calorie breakfast Treatment C 3 capsules S 42909/ Gelucire 44/14; 35/215 (total dose 105 mg/645 mg) after receiving a High Fat High Calorie breakfast Treatment D 1 capsules S 42909 105 mg after receiving a High Fat High Calorie breakfast Treatment E 6 capsules S 42909 105 mg (total dose 630 mg),after receiving a High Fat High Calorie breakfast Table 2:Sequence Treatment1 (n=2) A D B C2 (n=2) B A C D3 (n=2) C B D A4 (n=2) D C A B5 (n=2) A E B C6 (n=2) B A C E7 (n=2) C B E A8 (n=2) E C A B(n = number of subjects, 16 in total)Subjects will be resident for 3 days (until 24 hours post dose)

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/35

• Date of REC Opinion

  9 Feb 2011

• REC opinion

  Further Information Favourable Opinion