HealthyPhase 1NCT02448368

RDEA3170 Tablet and Capsule Bioavailability Study

A Phase 1 study testing RDEA3170,10 mg, RDEA3170, 2.5 mg and RDEA3170, 5 mg in people with Healthy, 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

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets. 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: Healthy
What is being tested?: RDEA3170,10 mg, RDEA3170, 2.5 mg and RDEA3170, 5 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 1 May 2015to 29 Jan 2016
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 of 4 to 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 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.

Show all 11Show fewer

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 cannot swallow multiple tablets or capsules.
Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

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, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.

Conditions: Healthy
Being tested: RDEA3170,10 mg, RDEA3170, 2.5 mg, RDEA3170, 5 mg, RDEA3170, 10 mg

What participants receive

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

RDEA3170,10 mgDrug
Also called Cohort 1
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
RDEA3170, 2.5 mgDrug
Also called Cohort 1
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
RDEA3170, 5 mgDrug
Also called Cohort 1
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
RDEA3170, 10 mgDrug
Also called Cohort 3
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
RDEA3170, 2.5 mgDrug
Also called Cohort 3
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Study groups in NCT02448368
Study group	Role	What they receive
Treatment A	Experimental	RDEA3170, 5 mg (FN24), administered in the fasted state. Receives: Drug: RDEA3170, 5 mg
Treatment B	Experimental	RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal). Receives: Drug: RDEA3170, 5 mg
Treatment C	Experimental	RDEA3170, 10 mg (FN25), administered in the fasted state. Receives: Drug: RDEA3170,10 mg
Treatment D	Experimental	RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal). Receives: Drug: RDEA3170,10 mg
Treatment E	Experimental	RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. Receives: Drug: RDEA3170, 2.5 mg
Treatment I	Experimental	RDEA3170, 10 mg (FN26), administered in the fasted state. Receives: Drug: RDEA3170, 10 mg
Treatment J	Experimental	RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal). Receives: Drug: RDEA3170, 10 mg
Treatment K	Experimental	RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. Receives: 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 is the maximum observed concentration of a drug after administration
Measured: Day 1, 5, 9, 13, 17
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax is the time of occurrence of cmax
Measured: Day 1, 5, 9, 13, 17
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Measured: Day 1, 5, 9, 13, 17
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Measured: Day 1, 5, 9, 13, 17
Apparent Terminal Half-life (t1/2)
t1/2 is a measure of apparent terminal half-life
Measured: Day 1, 5, 9, 13, 17
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
Cmax is the maximum observed concentration of a drug after administration
Measured: Day 1, 5, 9, 13, 17
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Measured: Day 1, 5, 9, 13, 17
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Measured: Day 1, 5, 9, 13, 17

Secondary outcomes (2)

Pharmacodynamics (PD) Profile of RDEA3170
Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.
Measured: Day -1, 1, 5, 9, 13, 17
Incidence of Treatment-Emergent Adverse Events
Measured: 8 weeks

Timeline

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

1 May 201529 Jan 2016

First posted19 May 2015 (estimated)
Study start1 May 2015
Primary completion26 Jun 2015
Study completion29 Jan 2016

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 HealthyStudies 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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02448368
Sponsor's protocol ID: RDEA3170-111
Status last verified: Nov 2017
First submitted: 30 Apr 2015
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170
ClinicalTrials.gov ID: NCT02448368
Acronym / sponsor ID: RDEA3170-111
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 1 May 2015 (actual)
Primary completion: 26 Jun 2015 (actual)
Study completion: 29 Jan 2016 (actual)
First posted: 19 May 2015 (estimated)
Results: Posted 20 Aug 2018

Clinical summary

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

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Treatment A	Experimental	Drug: RDEA3170, 5 mgRDEA3170, 5 mg (FN24), administered in the fasted state.
Treatment B	Experimental	Drug: RDEA3170, 5 mgRDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).
Treatment C	Experimental	Drug: RDEA3170,10 mgRDEA3170, 10 mg (FN25), administered in the fasted state.
Treatment D	Experimental	Drug: RDEA3170,10 mgRDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).
Treatment E	Experimental	Drug: RDEA3170, 2.5 mgRDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
Treatment I	Experimental	Drug: RDEA3170, 10 mgRDEA3170, 10 mg (FN26), administered in the fasted state.
Treatment J	Experimental	Drug: RDEA3170, 10 mgRDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
Treatment K	Experimental	Drug: RDEA3170, 2.5 mgRDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

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 of 4 to 7 mg/dL.
Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Key exclusion criteria (11 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 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.

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 mgAlso: Cohort 1Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.	Drug	Treatment C, Treatment D
RDEA3170, 2.5 mgAlso: Cohort 1Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.	Drug	Treatment E
RDEA3170, 5 mgAlso: Cohort 1Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.	Drug	Treatment A, Treatment B
RDEA3170, 10 mgAlso: Cohort 3Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.	Drug	Treatment I, Treatment J
RDEA3170, 2.5 mgAlso: Cohort 3Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.	Drug	Treatment K

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1, 5, 9, 13, 17
Cmax is the maximum observed concentration of a drug after administration
Time of Occurrence of Maximum Observed Concentration (Tmax)
Time frame: Day 1, 5, 9, 13, 17
Tmax is the time of occurrence of cmax
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
Time frame: Day 1, 5, 9, 13, 17
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
Time frame: Day 1, 5, 9, 13, 17
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Apparent Terminal Half-life (t1/2)
Time frame: Day 1, 5, 9, 13, 17
t1/2 is a measure of apparent terminal half-life
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
Time frame: Day 1, 5, 9, 13, 17
Cmax is the maximum observed concentration of a drug after administration
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
Time frame: Day 1, 5, 9, 13, 17
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
Time frame: Day 1, 5, 9, 13, 17
AUC 0-∞ is a meausre of total concentration from time zero to infinity

2 secondary outcomes

Pharmacodynamics (PD) Profile of RDEA3170
Time frame: Day -1, 1, 5, 9, 13, 17
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 weeks

Results and safety

Results posted to the registry on 20 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Sequence ABECD (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence AEBDC (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence EADBC (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence EDACB (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence DECAB (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence BACED (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence BCADE (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence CBDAE (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence CDBEA (Days 1, 5, 9, 13, and 17)	2	2
Cohort 1: Sequence DCEBA (Days 1, 5, 9, 13, and 17)	2	2
Cohort 3: Sequence IJK (Days 1, 5, and 9)	5	5
Cohort 3: Sequence JKI (Days 1, 5, and 9)	5	5
Cohort 3: Sequence KIJ (Days 1, 5, and 9)	5	5

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1, 5, 9, 13, 17. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Treatment A n = 19	Treatment C n = 20	Treatment E n = 20	Treatment I n = 15	Treatment K n = 15
Value	14.9 (12.5 to 17.8)	23.4 (19.3 to 28.2)	12.9 (11.2 to 14.9)	14.0 (12.1 to 16.3)	13.2 (11.2 to 15.5)

Treatment A vs Treatment E: Geometric Least Squares Mean Ratio: 232 (90% CI 202 to 266), Mixed Models Analysis
Treatment C vs Treatment E: Geometric Least Squares mean Ratio: 181 (90% CI 164 to 200), Mixed Models Analysis
Treatment I vs Treatment K: Geometric Least Squares mean Ratio: 106 (90% CI 91.5 to 124), Mixed Models Analysis

Population analysed: A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.

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

Time frame: Day 1, 5, 9, 13, 17. Median (Full Range). Unit: hr

Measure	Treatment A n = 19	Treatment B n = 20	Treatment C n = 20	Treatment D n = 20	Treatment E n = 20	Treatment I n = 15	Treatment J n = 15	Treatment K n = 15
Value	3.00 (2.05)	4.00 (1.69)	3.50 (1.74)	4.00 (1.05)	2.00 (1.54)	2.00 (2.71)	6.00 (2.45)	3.00 (2.66)

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

Time frame: Day 1, 5, 9, 13, 17. Geometric mean (95% Confidence Interval). Unit: ng·hr/mL

Measure	Treatment A n = 19	Treatment C n = 20	Treatment E n = 20	Treatment I n = 15	Treatment K n = 15
Value	91.2 (80.6 to 103)	185 (163 to 211)	109 (89.9 to 132)	149 (130 to 171)	115 (96.9 to 137)

Treatment A vs Treatment E: Geometric Least Squares mean Ratio: 170 (90% CI 147 to 195), Mixed Models Analysis
Treatment C vs Treatment E: Geometric Least Squares mean Ratio: 170 (90% CI 146 to 199), Mixed Models Analysis
Treatment I vs Treatment K: Geometric Least Squares mean Ratio: 129 (90% CI 114 to 146), Mixed Models Analysis

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

Time frame: Day 1, 5, 9, 13, 17. Geometric mean (95% Confidence Interval). Unit: ng·hr/mL

Measure	Treatment A n = 19	Treatment C n = 20	Treatment E n = 20	Treatment I n = 20	Treatment K n = 20
Value	95.7 (84.5 to 108)	192 (169 to 219)	121 (97.0 to 150)	161 (140 to 184)	123 (103 to 146)

Treatment A vs Treatment E: Geometric Least Squares mean Ratio: 161 (90% CI 139 to 187), Mixed Models Analysis
Treatment C vs Treatment E: Geometric Least Squares mean Ratio: 159 (90% CI 135 to 188), Mixed Models Analysis
Treatment I vs Treatment K: Geometric Least Squares mean Ratio: 131 (90% CI 116 to 147), Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 20 (0%)	1 of 20 (5%)	Not reported
Treatment B	0 of 20 (0%)	1 of 20 (5%)	Not reported
Treatment C	0 of 20 (0%)	0 of 20 (0%)	Not reported
Treatment D	0 of 20 (0%)	0 of 20 (0%)	Not reported
Treatment E	0 of 20 (0%)	0 of 20 (0%)	Not reported
Treatment I	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
Treatment J	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
Treatment K	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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, RDEA3170, 2.5 mg and RDEA3170, 5 mg in people with Healthy, 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 11 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 20 Aug 2018. 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 20 Aug 2018). 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: Day 1, 5, 9, 13, 17). The study lists 8 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 NCT02448368.

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 20 Aug 2018.