SAR114137: first doses in humans; version 1

• Research type

  Research Study

• Full title

  Randomized, double-blind, placebo-controlled study of the tolerability and pharmacokinetics of ascending single and 14 repeated daily oral doses of SAR114137 in healthy subjects with pharmacodynamic assessment in healthy postmenopausal female subjects and a pilot investigation of the effect of food (HMR 10-011)

• IRAS ID

  59535

• Contact name

  Steve Warrington

• Sponsor organisation

  sanofi-aventis R&D

• Eudract number

  2010-020542-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental treatment for pain caused by inflammation (as in osteoarthritis) and damaged nerves (as in diabetes).We're doing this study in 4 parts.Participants in parts 1-3 will be healthy men aged 18-45 years, and in Part 4 healthy post-menopausal women aged over 50 years.Participants will be in the study, as follows:* Part 1:up to 4 weeks* Part 2:up to 5 weeks* parts 3 or 4:up to 7 weeksThe study medicine has never been given to humans before, so we want to find out its side effects and blood levels.In Part 1, We'll test single doses in 56 healthy men.We'll start with a small dose, then increase it progressively.In Part 2, we'll test 2 single doses in 8 healthy men, one after an overnight fast, and the other after a high-fat breakfast - we want to know if food affects blood levels of the medicine. In parts 3 and 4, we'll test repeated doses for 14 days in 36 healthy men (Part 3) and 24 healthy post-menopausal women (Part 4).In Part 4, We'll also test blood and urine to see if the study medicine could reduce the breakdown of bone.In parts 1, 3 and 4, some Participants will take dummy medicine.In all parts, we might study how genes (pieces of DNA) affect how the body responds to or handles the study medicine.A pharmaceutical company, sanofi-aventis R&D, is funding the study.The study will take place at 1 centre in London.We'll recruit healthy Participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/56

• Date of REC Opinion

  2 Aug 2010

• REC opinion

  Favourable Opinion