Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.
Key facts
- Study ID
- NCT01037725
- Run by
- AstraZeneca
- People needed
- 64
- Starts
- 2009-12-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2010-07-14
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
- Healthy male and female volunteers. Females must be of non childbearing potential
You may not qualify if…
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
- History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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