If you are a healthy female aged between 18 and 55, then you may be eligible to participate in a study investigating a new drug being developed for the treatment of a condition called Multiple Sclerosis (MS).
Study Payment* £7,950.
*Terms & Conditions apply.
Study Information
Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new study drug being developed as a potential treatment for a condition known as Multiple Sclerosis (MS), which is a neurological condition in which the body’s immune system mistakenly attacks the protective lining surrounding nerve cells in the brain and spinal cord causing damage and inflammation.
The main objectives of the study are as follows:
- To investigate if there are any interactions between the study drug and a combined oral contraceptive (the pill) and to evaluate if these interactions impact the levels of the study drug or the pill in the blood.
- To investigate the safety of the study drug, and any side effects which may be associated with the study drug when it is given as multiple doses for up to 14 days.
If you participate in this study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 22 days (21 overnight stays) and complete a post study follow-up visit on Day 30 (a minimum of 10 days following the last dose of study drug). Therefore, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study.
Purpose and Timeline
This study is classed as a drug-drug interaction study and will consist of up to 22 healthy female participants. This means that participants will be given a drug (combined oral contraceptive pill) which has known effects and a known method of breakdown in the body and also given the study drug to determine if there is any interaction between the drugs in the body and whether administration of the study drug affects the safety, tolerability and levels of the pill in the blood.
On Days 5-16, participants will take once daily doses of the study drug before taking a single dose of both the study drug and combined oral contraceptive pill together on Day 17 with the final dose of the study drug to be administered on Day 18. Each participant will receive the study drug and the combined oral contraceptive pill in the form of coated tablets which participants will swallow with water.
Screening Visit
Day -35 to Day -2
Treatment Period Part 1
Day -1 to Day 5
Treatment Period Part 2
Day 5 to Day 21
Post Study Follow-up Visit
Day 30