Phase 1 Study of URC102 in Healthy Subjects
A Phase I, Placebo-controlled, Randomized, Double Blind, Single or Multiple Dose Study of URC102 in Healthy Male Volunteers of Korean and Caucasian to Assess Safety, Pharmacokinetics and Pharmacodynamics
1 other identifier
interventional
81
1 country
1
Brief Summary
To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2013
CompletedFirst Submitted
Initial submission to the registry
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 8, 2017
March 1, 2017
7 months
September 13, 2013
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with AE
1 week
Secondary Outcomes (2)
Plasma URC102 concentration
1 week
Blood uric acid
1 week
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
URC102
ACTIVE COMPARATORURC102
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male volunteers
You may not qualify if:
- Received other investigational drug within 12 weeks prior to the first dose of study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Lee HA, Yu KS, Park SI, Yoon S, Onohara M, Ahn Y, Lee H. URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers. Rheumatology (Oxford). 2019 Nov 1;58(11):1976-1984. doi: 10.1093/rheumatology/kez140.
PMID: 31056705DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Sang Yu, MD, PhD, MBA
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2013
First Posted
October 1, 2013
Study Start
May 23, 2013
Primary Completion
December 24, 2013
Study Completion
July 1, 2014
Last Updated
March 8, 2017
Record last verified: 2017-03