CG400549 Single Ascending Dose Study (NCT01085578) | Clinical Trial Compass
CompletedPhase 1
CG400549 Single Ascending Dose Study
Netherlands18 participantsStarted 2009-10
Plain-language summary
Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Sex : male
* 2\. Age : 18-55 years, inclusive
* 3\. BMI : 19-30 kg/m2
* 4\. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
* 5\. Medical history without major pathology
* 6\. Normal blood pressure (systolic 90-140 mmHg; diastolic 60-90 mmHg) and heart rate (45 90 beats per minute); minor deviations from these criteria could be accepted if considered to be clinically insignificant by the Medical Investigator
* 7\. Computerised (12-lead) ECG recording normal or showing no clinically relevant deviations as judged by the Medical Investigator
* 8\. Male subjects and their female sexual partners must use double-barrier contraception during the study period and for 90 days after follow-up
* 9\. All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Medical Investigator. In particular, liver enzymes (aspartate aminotransferase \[ASAT\] and alanine aminotransferase \[ALAT\]) must be within the normal range and creatine phosphokinase (CPK) must be within 2.0 times the normal range.
* 10\. Willingness to sign the written Informed Consent Form (ICF)
Exclusion Criteria:
* 1\. Evidence of clinically relevant pathology
* 2\. History of bacterial or vir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events