NCT01883167

Brief Summary

This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2013

Typical duration for phase_1 healthy

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

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

June 18, 2013

Last Update Submit

January 8, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • PK profile of RDEA3170 from plasma and urine and febuxostat from plasma

    Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance

    Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only)

Secondary Outcomes (2)

  • PD profile of RDEA3170 and febuxostat alone and in combination

    Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only)

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

    8 weeks

Study Arms (2)

Febuxostat

EXPERIMENTAL

Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd. Days 15-21: RDEA3170 10 mg or placebo qd.

Drug: RDEA3170 10 mgDrug: Febuxostat 40 mgDrug: placebo

RDEA3170

EXPERIMENTAL

Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd. Days 15-21: febuxostat 40 mg qd.

Drug: RDEA3170 10 mgDrug: Febuxostat 40 mgDrug: placebo

Interventions

RDEA3170 10 mgDRUG

RDEA3170 10 mg once daily (qd)

FebuxostatRDEA3170
Febuxostat 40 mgDRUG

Febuxostat 40 mg qd

FebuxostatRDEA3170
placeboDRUG

placebo qd

FebuxostatRDEA3170

Eligibility Criteria

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

You may qualify if:

  • body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
  • no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values, per the Investigator's judgment.
  • a screening serum urate level ≥ 4.5 mg/dL.

You may not qualify if:

  • history or suspicion of kidney stones.
  • history of cardiac abnormalities as assessed during screening, including abnormal and clinically relevant electrocardiogram changes and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years.
  • undergone major surgery within 3 months prior to Day 1.
  • donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening Period.
  • inadequate venous access or unsuitable veins for repeated venipuncture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

Related Publications (1)

  • Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19.

    PMID: 32951150DERIVED

MeSH Terms

Interventions

verinuradFebuxostat

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • S. Baumgartner

    Ardea Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)