RDEA3170 AME Study

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.