GoutPhase 1NCT02336594

RDEA3170 Bioavailability Study

A Phase 1 study testing RDEA3170 10 mg and RDEA3170 2.5 mg in people with Gout, run by Ardea Biosciences, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Gout
What is being tested?: RDEA3170 10 mg and RDEA3170 2.5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Mar 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity
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 ≤ 7 mg/dL
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Who cannot join

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 (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
Subject has inadequate venous access or unsuitable veins for repeated venipuncture
Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
Subject cannot swallow multiple tablets

Show all 9Show fewer

Subject is a heavy caffeine drinker
Subject is unwilling to comply with the dietary restrictions of the study
Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets

Conditions: Gout
Being tested: RDEA3170 10 mg, RDEA3170 2.5 mg
Medical subject headings: Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDEA3170 10 mgDrug
RDEA3170 2.5 mgDrug

Study groups in NCT02336594
Study group	Role	What they receive
Sequence ABCD	Experimental	2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat. Receives: Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg
Sequence BACD	Experimental	10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat Receives: Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg
Sequence ABDC	Experimental	2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat Receives: Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg
Sequence BADC	Experimental	10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat Receives: Drug: RDEA3170 10 mg; Drug: RDEA3170 2.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax)
Cmax of RDEA3170 in fasted condition.
Measured: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of RDEA3170 following various treatments.
Measured: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
AUC last of RDEA3170 in fasted condition.
Measured: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
AUC∞ of RDEA3170 the fasted condition.
Measured: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Apparent Terminal Half-life (t1/2)
t1/2 of RDEA3170 following various treatments.
Measured: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Cmax of RDEA3170 in high-fat fed state.
Measured: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets
AUC last of RDEA3170 in high-fat fed state.
Measured: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
AUC∞ of RDEA3170 in high-fat fed state.
Measured: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Cmax of RDEA3170 in low-fat fed state.
Measured: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
AUC last of RDEA3170 in low-fat fed state.
Measured: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
AUC∞ of RDEA3170 in low-fat fed state.
Measured: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.

Secondary outcomes (2)

Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.
Measured: Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.
Incidence of Treatment-Emergent Adverse Events
Measured: 7 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Mar 2015

First posted13 Jan 2015 (estimated)
Study startNov 2014
Primary completionJan 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GoutStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02336594
Sponsor's protocol ID: RDEA3170-110
Status last verified: Oct 2017
First submitted: 6 Nov 2014
Last updated: 13 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
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Uncontrolled Gout

All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets
ClinicalTrials.gov ID: NCT02336594
Acronym / sponsor ID: RDEA3170-110
Conditions: Gout
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jan 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 13 Jan 2015 (estimated)
Results: Posted 13 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence ABCD	Experimental	Drug: RDEA3170 10 mg, Drug: RDEA3170 2.5 mg2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
Sequence BACD	Experimental	Drug: RDEA3170 10 mg, Drug: RDEA3170 2.5 mg10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
Sequence ABDC	Experimental	Drug: RDEA3170 10 mg, Drug: RDEA3170 2.5 mg2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
Sequence BADC	Experimental	Drug: RDEA3170 10 mg, Drug: RDEA3170 2.5 mg10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity
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 ≤ 7 mg/dL
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Key exclusion criteria (9 listed)

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 (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
Subject has inadequate venous access or unsuitable veins for repeated venipuncture
Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RDEA3170 10 mg	Drug	Sequence ABCD, Sequence ABDC, Sequence BACD, Sequence BADC
RDEA3170 2.5 mg	Drug	Sequence ABCD, Sequence ABDC, Sequence BACD, Sequence BADC

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax of RDEA3170 in fasted condition.
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Tmax of RDEA3170 following various treatments.
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC last of RDEA3170 in fasted condition.
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞ of RDEA3170 the fasted condition.
Apparent Terminal Half-life (t1/2)
Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
t1/2 of RDEA3170 following various treatments.
Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Time frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax of RDEA3170 in high-fat fed state.
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Time frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC last of RDEA3170 in high-fat fed state.
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Time frame: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞ of RDEA3170 in high-fat fed state.
Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Time frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
Cmax of RDEA3170 in low-fat fed state.
AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Time frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC last of RDEA3170 in low-fat fed state.
AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Time frame: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
AUC∞ of RDEA3170 in low-fat fed state.

2 secondary outcomes

Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
Time frame: Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.
Incidence of Treatment-Emergent Adverse Events
Time frame: 7 weeks.

Results and safety

Results posted to the registry on 13 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABCD	3	3
Sequence BACD	4	4
Sequence ABDC	4	4
Sequence BADC	4	4

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Treatment A n = 15	Treatment B n = 15
Value	14.1 (11.7 to 16.8)	14.9 (11.9 to 18.8)

Treatment A vs Treatment B: Geometric Least Squares Mean Ratio (%): 107 (90% CI 95.2 to 120), Mixed Models Analysis

Primary outcome: Time of Occurrence of Maximum Observed Concentration (Tmax)

Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.. Median (Full Range). Unit: hr

Measure	Treatment A n = 15	Treatment B n = 15	Treatment C n = 15	Treatment D n = 15
Value	2.00 (1.00 to 6.00)	2.00 (1.00 to 4.00)	2.00 (1.00 to 6.00)	4.00 (1.50 to 8.00)

Primary outcome: Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)

Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.. Geometric mean (95% Confidence Interval). Unit: ng·hr/mL

Measure	Treatment A n = 15	Treatment B n = 15
Value	119 (96.8 to 146)	114 (85.7 to 153)

Treatment A vs Treatment B: Geometric Least Squares mean Ratio (%): 97.3 (90% CI 85.6 to 111), Mixed Models Analysis

Primary outcome: Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)

Time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.. Geometric mean (95% Confidence Interval). Unit: ng·hr/mL

Measure	Treatment A n = 15	Treatment B n = 15
Value	131 (105 to 164)	130 (95.9 to 176)

Treatment A vs Treatment B: Geometric Least Squares mean Ratio (%): 100 (90% CI 87.3 to 115), Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 15 (0%)	0 of 15 (0%)	Not reported
Treatment B	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Treatment C	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Treatment D	0 of 15 (0%)	3 of 15 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

J. Hall, MD study director

Ardea Biosciences, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RDEA3170 10 mg and RDEA3170 2.5 mg in people with Gout, run by Ardea Biosciences, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.