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OpenTrials
Completed

NCT Number: NCT01953497

Phase 1 Study of URC102 in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers

Exclusion criteria

  • Received other investigational drug within 12 weeks prior to the first dose of study drug

Treatment and study plan

URC102

Drug

Placebo

Drug

Primary outcomes

  1. Number of participants with AE

    Time frame: 1 week

Secondary outcomes

  1. Plasma URC102 concentration

    Time frame: 1 week

  2. Blood uric acid

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 1, 2013
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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