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RDEA3170 Bioavailability Study

NCT ID: NCT02336594

Last Updated: 2017-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-03-31

Brief Summary

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This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.

Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence ABCD

2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 2.5 mg

Intervention Type DRUG

Sequence BACD

10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 2.5 mg

Intervention Type DRUG

Sequence ABDC

2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 2.5 mg

Intervention Type DRUG

Sequence BADC

10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 2.5 mg

Intervention Type DRUG

Interventions

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RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 2.5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity
* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2
* Subject has a Screening serum urate level ≤ 7 mg/dL
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Exclusion Criteria

* Subject has a history or suspicion of kidney stones
* Subject has undergone major surgery within 3 months prior to Screening
* Subject donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture
* Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
* Subject cannot swallow multiple tablets
* Subject is a heavy caffeine drinker
* Subject is unwilling to comply with the dietary restrictions of the study
* Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ardea Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Hall, MD

Role: STUDY_DIRECTOR

Ardea Biosciences, Inc.

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RDEA3170-110

Identifier Type: -

Identifier Source: org_study_id