NCT02608710

Brief Summary

The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

November 15, 2015

Last Update Submit

August 31, 2016

Conditions

Gout

Outcome Measures

Primary Outcomes (21)

  • Maximum observed concentration (Cmax)

    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Cmax

    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • Cmax

    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

  • Time of Occurrence of maximum observed concentration (Tmax)

    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Area under the plasma concentration time curve (AUC)

    Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Tmax

    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • AUC

    Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • Tmax

    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

  • AUC

    Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

  • Serum urate concentration

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Urine uric acid excretion amount

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Renal clearance of uric acid

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Fractional excretion of uric acid

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

    Days -1, 1, 5 and 9

  • Serum urate concentration

    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • Urine uric acid excretion amount

    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • Renal clearance of uric acid

    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • Fractional excretion of uric acid

    Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

    Days -1, 1 and 7

  • Serum urate concentration

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

  • Urine uric acid excretion amount

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

  • Renal Clearance of Uric Acid

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

  • Fractional excretion of uric acid

    Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

    Days -1, 1, 7 and 8

Secondary Outcomes (7)

  • Incidence of Adverse Events in terms of changes in laboratory parameters

    6 weeks

  • Incidence of Adverse Events in terms of electrocardiogram parameters

    6 weeks

  • Incidence of Adverse Events in terms of vital signs

    6 weeks

  • Incidence of Adverse Events in terms of physical examination findings

    6 weeks

  • Apparent terminal half-life (t1/2)

    Days -1, 1, 5 and 9

  • +2 more secondary outcomes

Study Arms (3)

Single Dose

EXPERIMENTAL

Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.

Drug: RDEA3170 4.5 mgDrug: RDEA3170 6 mgDrug: RDEA3170 12 mg

Multiple Dose

EXPERIMENTAL

RDEA3170 12 mg once daily (qd)

Drug: RDEA3170 12 mg

Single Dose Food Effect

EXPERIMENTAL

Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.

Drug: RDEA3170 6 mg

Interventions

RDEA3170 4.5 mgDRUG
Single Dose
RDEA3170 6 mgDRUG
Single DoseSingle Dose Food Effect
RDEA3170 12 mgDRUG
Multiple DoseSingle Dose

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
  • Subject has a Screening serum urate level 4 to 7 mg/dL
  • Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

You may not qualify if:

  • Subject has a history or suspicion of kidney stones.
  • Subject has undergone major surgery within 3 months prior to Screening.
  • Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
  • Subject has clinically unacceptable physical examination, per the Investigator's judgment.
  • Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
  • Subject has Screening clinical safety laboratory parameters (serum chemistry \[other than serum creatinine and serum urate\], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
  • Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
  • Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
  • Subject has a history of cardiac abnormalities
  • Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Gout

Interventions

verinurad

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • J. Hall, MD

    Ardea Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-08

Locations

US(1)