RDEA3170 and Febuxostat Drug Interaction Study

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

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Febuxostat

Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.

Days 15-21: RDEA3170 10 mg or placebo qd.

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 10 mg once daily (qd)

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 40 mg qd

placebo

Intervention Type DRUG

placebo qd

RDEA3170

Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd.

Days 15-21: febuxostat 40 mg qd.

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

RDEA3170 10 mg once daily (qd)

Febuxostat 40 mg

Intervention Type DRUG

Febuxostat 40 mg qd

placebo

Intervention Type DRUG

placebo qd

Interventions

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RDEA3170 10 mg

RDEA3170 10 mg once daily (qd)

Intervention Type DRUG

Febuxostat 40 mg

Febuxostat 40 mg qd

Intervention Type DRUG

placebo

placebo qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values, per the Investigator's judgment.
* a screening serum urate level ≥ 4.5 mg/dL.

Exclusion Criteria

* history or suspicion of kidney stones.
* history of cardiac abnormalities as assessed during screening, including abnormal and clinically relevant electrocardiogram changes and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years.
* undergone major surgery within 3 months prior to Day 1.
* 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 the Screening Period.
* inadequate venous access or unsuitable veins for repeated venipuncture.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes