Pharmacokinetic study with Niacin and Niaspan

• Research type

  Research Study

• Full title

  A Randomized, Single-Dose, Four Period Study to Explore the Pharmacokinetic Properties of Two Niacin formulations Versus Niaspan Administered to Healthy Volunteers

• IRAS ID

  42971

• Contact name

  Stuart J Mair

• Sponsor organisation

  Cerenis Therapeutics S.A.

• Eudract number

  2009-017302-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is being conducted by Cerenis Therapeutics S.A. and is designed to investigate different types of niacin (in terms of the duration of the effect) when taken together with aspirin by comparing blood levels of niacin between the different treatments. To make it more convenient and effective for patients to take niacin, the sponsor wishes to develop a single tablet containing both the optimum dose of niacin and aspirin so that the effect of both treatments can be prolonged and the effect of aspirin in terms of reducing the effect ofluhing can be maximised.Both niacin and aspirin are licensed in the UK and other countries. Niacin is a licensed treatment for altered blood lipids (fats) eg high cholesterol but its use is limited by a side effect known afluhing (Signs ofluhing include redness, warmth, tingling, itching, burning, and crawling sensation of the skin.). Aspirin is a common painkiller and is also licensed as a treatment to reduce the risk of blood clots in patients who may be at increased risk of heart attacks or strokes. Aspirin is already recommended to be taken at the same time as niacin to reduce the risk ofluhing. This does not represent a problem for most patients as many people with high cholesterol are also at increased risk of suffering from heart attacks and strokes and may benefit from taking aspirin.This study will take place at Quotient Clinical in Edinburgh. For each participant the study involves 2 screening visits and 4 resident periods in the clinical unit and will last for approximately 7 weeks in total. As this is a healthy volunteer study there is not expected to be any benefit for participants.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/32

• Date of REC Opinion

  25 Jan 2010

• REC opinion

  Favourable Opinion