Phase 1 Study(Additional) of URC102 in Healthy Subjects

NCT ID: NCT02524678

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-05

Study Completion Date

2016-03-28

Brief Summary

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The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in healthy subjects.

Detailed Description

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Tolerability, safety, and pharmacokinetics (PK) of URC102 will be assessed after 7-day repeated oral dose in healthy adult Korean males. In addition, pharmacodynamic (PD) response of blood and urinary uric acid levels will be assessed.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

URC102

URC102

Group Type ACTIVE_COMPARATOR

URC102

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

URC102

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers

Exclusion Criteria

* Participated in other clinical study within past 3 months prior to receiving an IP administration
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31056705 (View on PubMed)

Other Identifiers

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URC004KR

Identifier Type: -

Identifier Source: org_study_id

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