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RDEA3170 AME Study

A

Ardea Biosciences

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: RDEA3170 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910506
RDEA3170-106

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

RDEA3170
Experimental group
Treatment:
Drug: RDEA3170 10 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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