RDEA3170 AME 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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of \[14 C\]RDEA3170 in healthy adult male subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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RDEA3170

Group Type EXPERIMENTAL

RDEA3170 10 mg

Intervention Type DRUG

Interventions

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RDEA3170 10 mg

Intervention Type DRUG

Other Intervention Names

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RDEA3170 10 mg dose oral solution with 500 μCi of [14C]RDEA3170

Eligibility Criteria

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Inclusion Criteria

* Body weight ≥ 50 kg (110 lbs.) and body mass index ≥ 18 and ≤ 30 kg/m2.
* No clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.
* Screening serum urate level ≤ 7.0 mg/dL.
* Subject has a minimum of 1 bowel movement a day.

Exclusion Criteria

* History or suspicion of kidney stones.
* History of gastrointestinal ulcers, Helicobacter pylori infection, or other disorders of gastric pH.
* History of previous surgery on the stomach or small intestine (appendectomy is acceptable). Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 6 weeks prior to Day 1.
* Inadequate venous access or unsuitable veins for repeated venipuncture.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes