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 range18 Years – 55 Years
SexMALE
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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…
What they're measuring
1
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events