RDEA3170 AME Study

Phase 1CompletedNCT01910506

Ardea Biosciences, Inc.8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RDEA3170 10 mgDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Characteristics of AME in terms of pharmacokinetics (PK), metabolism, and excretion

PK profile in terms of AUC, Tmax, Cmax, t1/2, Ae, CLr, and CL/F. AUC: area under the concentration-time curve; Tmax: time to reach maximum concentration; Cmax: maximum concentration; t1/2: apparent terminal half-life; Ae: amount of compound excreted in urine unchanged; CLr: renal clearance; CL/F: total body clearance corrected for bioavailability Metabolic profile of RDEA3170 in plasma, urine, and feces. Excretion in terms of recovery of radioactivity in urine and feces.

Time frame: Day 1 predose, 15, 30, 45 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36, 48, 54, 60, 72 hrs postdose (blood and plasma only); Day 1, -12 to 0, 0-6, 6-12, 12-24 hrs postdose (urine and feces only)

Secondary Outcomes

Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

Time frame: 5 weeks

Data from ClinicalTrials.gov

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