A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914
Completed · Phase 1 · Has a placebo group
Conditions studied: Gonococcal (GC) Infection
In brief
The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.
Key facts
- Study ID
- NCT01929629
- Run by
- AstraZeneca
- People needed
- 100
- Starts
- 2013-09-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2014-04-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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