A Phase I Study to Assess the Effect of GRC 4039 on PK of Midazolam

• Research type

  Research Study

• Full title

  A Phase I Study to Assess the Effect of GRC 4039 on the Pharmacokinetics of Midazolam in Healthy Male Subjects

• IRAS ID

  121302

• Contact name

  Jim Bush

• Sponsor organisation

  Glenmark

• Eudract number

  2012-005566-35

• ISRCTN Number

  N/A

• Research summary

  The study drug is being developed as a potential treatment for some long-term inflammatory conditions such as Rheumatoid Arthritis (a disease that causes inflammation of the joints) and Asthma (a disease that causes inflammation of the airways). The study drug belongs to a class of drugs known as phosphodiesterase 4 (PDE-4) inhibitors. PDE-4 is an enzyme which plays a role in activating the inflammatory processes in the body and therefore inhibiting this enzyme will help prevent the development of these inflammatory responses. fluilast is an example of a PDE-4 inhibitor which is licensed to treat chronic bronchitis (long term inflammation and swelling of the lining of the airways). Often in real-life, people may be required to take more than one medication at the same time. These other medications may be broken down in the body by a specific enzyme. The study drug may block or activate the enzymes that are responsible for breaking down these other medications leading to either increased or reduced levels of the concomitantly administered medications in the bloodstream. Midazolam (an already marketed drug used to induce sedation and treat seizures) is broken down in the body by a specific enzyme (CYP3A4) which is the same enzyme that breaks down other drugs such as oral contraceptives, antihistamines, anti-asthmatics, antibiotics and corticosteroids. Therefore, if the study drug does block or activate this enzyme, the levels of Midazolam will be higher or lower in the bloodstream than anticipated. It can then be assumed that the same effect will be seen in other marketed drugs. This is a single site study involving up to 36 healthy adult male subjects. Each subject will receive a single oral dose of Midazolam (2 mg) on Days 1 and 9. On Days 2 to 9, subjects will receive an oral dose of the study drug (6 mg) once daily. According to this study design, subjects will receive both the study drug and Midazolam on Day 9 which would give an idea about any possible interactions. The study is expected to last up to 6 weeks from the time of screening till the last post-study visit.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0008

• Date of REC Opinion

  22 Jan 2013

• REC opinion

  Favourable Opinion