Overview

This trial has been completed.

Condition healthy
Treatments urc102, placebo
Phase phase 1
Sponsor JW Pharmaceutical
Start date May 2013
End date December 2013
Trial size 81 participants
Trial identifier NCT01953497, URC001KR

Summary

To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Primary purpose treatment
Masking participant, investigator
Arm
(Placebo Comparator)
Placebo
placebo
(Active Comparator)
URC102
urc102

Primary Outcomes

Measure
Number of participants with AE
time frame: 1 week

Secondary Outcomes

Measure
Plasma URC102 concentration
time frame: 1 week
Blood uric acid
time frame: 1 week

Eligibility Criteria

Male participants from 20 years up to 50 years old.

Inclusion Criteria: - Healthy male volunteers Exclusion Criteria: - Received other investigational drug within 12 weeks prior to the first dose of study drug

Additional Information

Official title 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
Principal investigator Kyung-Sang Yu, MD, PhD, MBA
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by JW Pharmaceutical.