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Completed

NCT Number: NCT01910506

RDEA3170 AME Study

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RDEA3170 10 mg

Drug

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

Primary outcomes

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

    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)

    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 outcomes

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

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1 Absorption, Metabolism and Excretion Study of [14C]RDEA3170 Orally Administered to Healthy Adult Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2013
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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