Phase
Condition
Gout (Hyperuricemia)
Healthy Volunteers
Treatment
Placebo
NNC4004-0002
Clinical Study ID
Ages 35-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females 35 to 75 years of age at the time of signing the informed consentform (ICF).
Considered to be generally healthy based on medical history, physical examination,and the re-sults of vital signs, electrocardiogram, and clinical laboratory testsperformed during the screening visit, as judged by the investigator.
Body mass index (BMI) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) atscreening.
Serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dL) to less than or equal (≤) 12 mg/dL on 2 consecutive screening samples (thefirst at the screening visit [V1], and the second taken at V2 [day -1]; samples atleast 7 days apart).
Exclusion
Exclusion Criteria:
Female who is pregnant, breastfeeding, or intends to become pregnant or is ofchildbearing po-tential and not using an adequate contraceptive method.
Male of reproductive age who, or whose female partner(s), is not using an adequatecontraceptive method.
Present or prior history of gout, or present or prior use of serum Uric acid (sUA)lowering medication.
Serious cardiovascular or hepatic disease, current or past malignancies, or chronicdebilitating neurologic, gastrointestinal, or inflammatory diseases.
History or current diagnosis of chronic history kidney disease.
Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) valuesgreater than (>) 2 multiply by (×) upper limit normal (ULN) or total bilirubin >1.5×ULN.
Study Design
Connect with a study center
PAREXEL International - Early Phase Clinical Unit Baltimore
Baltimore, Maryland 21225
United StatesActive - Recruiting
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland 21225
United StatesActive - Recruiting
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