A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914 (NCT01929629) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914
United States100 participantsStarted 2013-09
Plain-language summary
The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.
Who can participate
Age range18 Years – 55 Years
SexALL
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:
* Healthy male and female (of non-childbearing potential)subjects aged 18 to55 years (inclusive).
* Have a body mass index (BMI) between 18.00 and 30.50 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Male subjects should be willing to use barrier contraception, ie, condoms, from the day of dose administration until at least 3 months after dose administration of the IP
Exclusion Criteria:
* History of any important clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks from the first administration of IP as judged by the PI
* History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms \>3 times a week, or blood in stool in previous 6 months not related to anal trauma
What they're measuring
1
Description of the safety profile in terms of adverse events; blood pressure, heart rate and body temperature; electrocardiograms; telemetry; clinical chemistry ; haematology and physical examination
Timeframe: From admission on day -1 until follow up. ( Max 16 days)