Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT01872832
Eligibility Criteria:
Inclusion Criteria:
* Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
* Healthy adult male subject born in Japan.
* Subject has parents and grandparents who are Japanese.
* Subject is in possession of a valid Japanese passport.
* All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
* Screening serum urate level ≥ 4.5 mg/dL.
* Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has a normal or clinically acceptable physical examination.
* Subject has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.
Exclusion Criteria:
* Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).
* Positive test for active hepatitis B or hepatitis C infection.
* History or suspicion of kidney stones.
* Undergone major surgery within 3 months prior to Day 1.
* Exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day 1 or is currently participating in another study of an investigational drug (or medical device).
* Prior exposure to RDEA3170.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01872832
Study Brief:
Protocol Section:
NCT01872832