RDEA3170 AME Study
A Phase 1 Absorption, Metabolism and Excretion Study of [14C]RDEA3170 Orally Administered to Healthy Adult Male Subjects
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2013
CompletedFirst Posted
Study publicly available on registry
July 29, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 9, 2014
January 1, 2014
1 month
July 25, 2013
January 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 (1)
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
5 weeks
Study Arms (1)
RDEA3170
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Madison, Wisconsin, 53704, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
S. Baumgartner
Ardea Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2013
First Posted
July 29, 2013
Study Start
August 1, 2013
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
January 9, 2014
Record last verified: 2014-01