PQ912 - Midazolam and Omeprazole DDI Study

• Research type

  Research Study

• Full title

  A Phase I, Open Label Study to Assess the Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole in Healthy Male Subjects

• IRAS ID

  156293

• Sponsor organisation

  Probiodrug

• Eudract number

  2014-001883-36

• Research summary

  PQ912 is an investigational drug which is being developed with an aim to help people with Alzheimer’s Disease (AD) in the future. \nAD is the most common form of dementia. It is progressive, irreversible, and often affects the elderly population with symptoms including memory loss, confusion and problems with thinking and reasoning. AD is thought to be caused by loss of neurons (i.e. nerve cells which transmit electrical signals) in the brain. This loss of neurons is thought to be caused by tangling of neurons or formation of plaques. This may be caused by chemical changes in the brain. PQ912 is thought to inhibit these changes and may offer therapeutic benefit to AD patients in the future.\nTo date 206 healthy volunteers have received the study drug, in a previous clinical trial performed. \nThis is a drug interaction study. We will be assessing if PQ912 affects the way that the body handles certain drugs when they are given at the same time. The other drugs that are being tested with the Study Drug are omeprazole and midazolam. Both omeprazole and midazolam are licensed.\nOmeprazole is commonly used to reduce the amount of acid produced in the stomach to treat conditiosn such as acid reflux and stomach ulcers. Omeprazole is broken down by a particular enzyme called CYP2C19, which is the same enzyme that a lot of other drugs are broken down by. For this reason Omeprazole is recommended to evaluate drug interactions which may increase or reduce the ability of CYP2C19 to break down these kinds of drugs.\nMidazolam is commonly used to treat people that cannot sleep, people who suffer from acute seizures and for causing a deliberate or planned feeling of drowsiness. Midazolam is broken down by a particular enzyme called CYP3A4, which is the same enzyme that a lot of other drugs are broken down by. For this reason midazolam is recommended to evaluate drug interactions which may increase or reduce the ability of CYP3A4 to break down these kinds of drugs.\n\nIf PQ912 has any impact on either CYP2C19 or CYP3A4, then this will affect the amount of omeprazole or midazolam that gets into the blood stream and it can be assumed that the same effect will occur with other medications that are regulated or broken down in the same way. \n \n

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  14/EE/0190

• Date of REC Opinion

  3 Jun 2014

• REC opinion

  Further Information Favourable Opinion