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RDEA3170 AME Study

Sponsor
Ardea Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01910506
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
3
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: RDEA3170 10 mg
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Absorption, Metabolism and Excretion Study of [14C]RDEA3170 Orally Administered to Healthy Adult Male Subjects
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: RDEA3170

Drug: RDEA3170 10 mg
Other Names:
  • RDEA3170 10 mg dose oral solution with 500 μCi of [14C]RDEA3170

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Characteristics of AME in terms of pharmacokinetics (PK), metabolism, and excretion [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)]

      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.

    Secondary Outcome Measures

    1. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Madison Wisconsin United States 53704

    Sponsors and Collaborators

    • Ardea Biosciences, Inc.

    Investigators

    • Study Director: S. Baumgartner, Ardea Biosciences, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ardea Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT01910506
    Other Study ID Numbers:
    • RDEA3170-106
    First Posted:
    Jul 29, 2013
    Last Update Posted:
    Jan 9, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Verinurad

    Study Results

    No Results Posted as of Jan 9, 2014