2-OHOA single ascending dose study V01

• Research type

  Research Study

• Full title

  A placebo-controlled, single-ascending dose study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of orally administered 2-OHOA

• IRAS ID

  84914

• Sponsor organisation

  Bridge BioResearch Testing Services Ltd

• Eudract number

  2011-002124-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  2-Hydroxy oleic acid (2-OHOA) is a new drug that is being developed for the treatment of obesity and type 2 diabetes. Obesity is a common condition that is accompanied by other conditions such as type 2 diabetes, high blood pressure and effects on blood vessels. Weight reduction is associated with a significant improvement of health. Weight control drugs are available but the effectiveness of these treatments is modest at best. Hence, there is a need for more effective weight control drugs.It has been shown that long-term intake of olive oil can have beneficial effects on body weight and accompanying conditions. It is thought that the major component of olive oil, oleic acid, is responsible for these beneficial effects. 2-OHOA is a chemically modified version of naturally occurring oleic acid. It is thought that the chemical modification will increase the beneficial effects.This study will investigate safety, tolerability and pharmackinetics of 2-OHOA when given as a single dose. It is planed that six dose levels will be included in the study. Study participants will be healthy males aged 18-45 who weigh 100kg or less. The study will be conducted at Veeda Clinical Research, Plymouth.Individual participation will last approximately 15 days. Total study duration approximately 4 months.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0086

• Date of REC Opinion

  15 Aug 2011

• REC opinion

  Further Information Favourable Opinion