Source: https://www.geneesmiddelenonderzoek.nl/en/meedoen/de-onderzoeken/pra-133871-part-1
Timestamp: 2019-02-21 20:40:11
Document Index: 66193717

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PRA-133871 (part 1) › PRA Health Sciences
PRA-133871 (part 1) Duchenne Muscular Dystrophy € 827,-
You will receive a gross compensation of €827,- for participation in one of the groups below and you will receive €25,- extra for the short visit.
The study consists of one period in which you will stay in our research facility in Groningen for 5 days (4 nights).
Information sheet PRA-133871 (part 1)
This study consists of two parts; Part 1 and Part 2. The remainder of this document only refers to Part 1.
Part 1 of this study will consist of 1 period during which you will stay in our clinical research center in Groningen, UMCG location for 5 days (4 nights). During Part 1 of this study you will receive the study drug or placebo once in the form of an oral tablet.
Blood samples will be taken and urine will be collected regularly during the study.
Adverse effects observed during the first parts were: headache, nausea, abdominal pain, stomachache, bloating, flatulence, stomach discomfort, hunger, dry mouth, muscle pain, pain arms, chest muscle stiffness, muscle cramps and pain in the lower jaw, muscle twitching buttock, muscle cramp thigh, itching both hands, lower back pain, skin irritation at holter and ECG stickers, hematoma at venipuncture site, flu, common cold, nasal congestion, postural dizziness, dizziness, transpiration, sore throat, restlessness, tiredness, sleepiness, anxiety, loose stools, cannula site reaction, increased frequency urination, salivation increased, fast heartbeat, nosebleed, pink eye, sore eye, toothache, higher blood levels of liver enzymes, fungal infection in lower part of the esophagus, and erosion of the intestinal wall in the first part of the duodenum and the stomach wall. At this time it is not known if these effects are related to the study compound as the study is still blinded.
You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening in Groningen.
You are a healthy male between 18 and 45 years old. You can only participate in this study if you do nog smoke or smoke less than 5 cigarettes per day. Since the metabolism of the drug in the body can vary based on ethnicity, only caucasion volunteers can participate. Means, you belong to or originates from one of the original people of Europe, the Middle east or North Africa, or the Indian subcontinent.
Group 12a: 28 January – 01 February 2018
Group 12b: 04 – 08 February 2018
Group 12c: 27 February – 03 March 2018
The follow up visit will be conducted 2 to 5 days after departure from the research facility.
26 Feb 2018 up to and including 2 Mar 2018
27 Feb 2018 up to and including 3 Mar 2018