Effects of SB648868 on the body's response to hypoglycaemic stress

• Research type

  Research Study

• Full title

  Effects of SB-649868 and Alprazolam on the Neuroendocrine and Sympathetic Responses to Insulin-Induced Hypoglycaemia in Healthy male subjects.

• IRAS ID

  69241

• Contact name

  Annelize Koch

• Sponsor organisation

  GlaxoSmithKline Research & Development

• Eudract number

  Version 00

• Research summary

  SB-649868 is an oral drug, which blocks the orexin receptors in the brain associated with sleep and the body's response to stress. Doses up to 80mg have been previously investigated for the treatment of insomnia (sleeping difficulties) in multiple trials involving 246 healthy male and female volunteers and 52 male patients with insomnia. This study will evaluate the effect of SB-649868 at doses of up to 10 mg on the body's response to hypoglycaemia (low blood sugar, which is used as a stress test)and compare it to the effects of alprazolam a marketed sedative drug used as a control drug in this study) and placebo(pill without the active drug). We expect hypothetically that SB-649868 will reduce the stress response to hypoglycaemia. The results of this study may guide the design of further clinical trials in anxiety related disorders. The study will be conducted in a specialist clinical research unit with adequate facilities with regard to safety and compliance. It will consist of 1 screening visit, 3 in-patient treatment sessions (1 « days each, separated by 2 weeks)and a follow-up visit, taking approximately 12 weeks for each subject in total. During each of the treatment sessions, the first group of 12 participants will be given an insulin injection directly into a vein following a single oral dose of SB-649868 10 mg, alprazolam 0.02mg/kg, or placebo, allocated to them in a random order. Blood samples will be taken to measure blood sugar, hormones, and the study drug concentrations and the subjects will complete questionnaires about mood and behaviour. Depending on the results from the first group of subjects, a second group of 12 healthy subjects may be given 2 oral doses of SB-649868(between 2 and 10mg) and placebo, in 3 treatment sessions, and undergo the same tests.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0056

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Favourable Opinion