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CompletedNCT02448368Updated Aug 20, 2018Results posted

RDEA3170 Tablet and Capsule Bioavailability Study

A Phase 1 interventional study of RDEA3170,10 mg and RDEA3170, 2.5 mg in Healthy, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by Ardea Biosciences, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Basic science

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Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

First submitted after Ardea Biosciences, Inc. became part of AstraZeneca.

Browse Ardea Biosciences, Inc. studies →All AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is able to understand the study procedures and the risks involved, and is willing to provide written before the first study-related activity.
  • Subject has a body weight ≥ 50 kg (110 lbs.) and a ≥ 18 and ≤ 40 kg/m2.
  • Subject has a Screening serum urate level of 4 to 7 mg/dL.
  • Subject is free of any disease or medical condition, per the Investigator's judgment.

Exclusion criteria

Exclusion Criteria:

  • 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 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 at the Screening visit.
  • Subject has clinically relevant abnormalities in 12-lead , 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Treatment A

    RDEA3170, 5 mg (FN24), administered in the fasted state.

    Drug: RDEA3170, 5 mg

  • Experimental
    Treatment B

    RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).

    Drug: RDEA3170, 5 mg

  • Experimental
    Treatment C

    RDEA3170, 10 mg (FN25), administered in the fasted state.

    Drug: RDEA3170,10 mg

  • Experimental
    Treatment D

    RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).

    Drug: RDEA3170,10 mg

  • Experimental
    Treatment E

    RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

    Drug: RDEA3170, 2.5 mg

  • Experimental
    Treatment I

    RDEA3170, 10 mg (FN26), administered in the fasted state.

    Drug: RDEA3170, 10 mg

  • Experimental
    Treatment J

    RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).

    Drug: RDEA3170, 10 mg

  • Experimental
    Treatment K

    RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.

    Drug: RDEA3170, 2.5 mg

Interventions

  • DrugRDEA3170,10 mg

    Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

    Also known as: Cohort 1

  • DrugRDEA3170, 2.5 mg

    Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

    Also known as: Cohort 1

  • DrugRDEA3170, 5 mg

    Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

    Also known as: Cohort 1

  • DrugRDEA3170, 10 mg

    Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

    Also known as: Cohort 3

  • DrugRDEA3170, 2.5 mg

    Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

    Also known as: Cohort 3

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Cmax is the maximum observed concentration of a drug after administration

    Time frame: Day 1, 5, 9, 13, 17

  2. Time of Occurrence of Maximum Observed Concentration (Tmax)

    Tmax is the time of occurrence of cmax

    Time frame: Day 1, 5, 9, 13, 17

  3. 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

    Time frame: Day 1, 5, 9, 13, 17

  4. Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)

    AUC 0-∞ is a meausre of total concentration from time zero to infinity

    Time frame: Day 1, 5, 9, 13, 17

  5. Apparent Terminal Half-life (t1/2)

    t1/2 is a measure of apparent terminal half-life

    Time frame: Day 1, 5, 9, 13, 17

  6. 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

    Time frame: Day 1, 5, 9, 13, 17

  7. 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

    Time frame: Day 1, 5, 9, 13, 17

  8. 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

    Time frame: Day 1, 5, 9, 13, 17

Secondary outcomes

  1. 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.

    Time frame: Day -1, 1, 5, 9, 13, 17

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: 8 weeks

07

Results

Posted Aug 20, 2018

Participant flow

35 participants were randomized

Participant flow — Overall Study
MilestoneCohort 1: Sequence ABECD (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence AEBDC (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence EADBC (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence EDACB (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence DECAB (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence BACED (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence BCADE (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence CBDAE (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence CDBEA (Days 1, 5, 9, 13, and 17)Cohort 1: Sequence DCEBA (Days 1, 5, 9, 13, and 17)Cohort 3: Sequence IJK (Days 1, 5, and 9)Cohort 3: Sequence JKI (Days 1, 5, and 9)Cohort 3: Sequence KIJ (Days 1, 5, and 9)
Started2222222222555
Completed2222222222555
Not completed0000000000000

Outcome measures

PrimaryMaximum Observed Plasma Concentration (Cmax)

Cmax is the maximum observed concentration of a drug after administration

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax)
ng/mLTreatment ATreatment CTreatment ETreatment ITreatment K
Maximum Observed Plasma Concentration (Cmax)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)
Statistical analysis
  • Treatment A vs Treatment E · Mixed Models Analysis · Geometric least squares mean ratio: 232 · 90% CI 202 to 266A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment C vs Treatment E · Mixed Models Analysis · Geometric least squares mean ratio: 181 · 90% CI 164 to 200A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment I vs Treatment K · Mixed Models Analysis · Geometric least squares mean ratio: 106 · 90% CI 91.5 to 124A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
PrimaryTime of Occurrence of Maximum Observed Concentration (Tmax)

Tmax is the time of occurrence of cmax

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Median · hr
Time of Occurrence of Maximum Observed Concentration (Tmax)
hrTreatment ATreatment BTreatment CTreatment DTreatment ETreatment ITreatment JTreatment K
Time of Occurrence of Maximum Observed Concentration (Tmax)3.00 ± 2.054.00 ± 1.693.50 ± 1.744.00 ± 1.052.00 ± 1.542.00 ± 2.716.00 ± 2.453.00 ± 2.66
PrimaryArea 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

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · ng·hr/mL
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
ng·hr/mLTreatment ATreatment CTreatment ETreatment ITreatment K
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)91.2 (80.6 to 103)185 (163 to 211)109 (89.9 to 132)149 (130 to 171)115 (96.9 to 137)
Statistical analysis
  • Treatment A vs Treatment E · Mixed Models Analysis · Geometric least squares mean ratio: 170 · 90% CI 147 to 195A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment C vs Treatment E · Mixed Models Analysis · Geometric least squares mean ratio: 170 · 90% CI 146 to 199A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment I vs Treatment K · Mixed Models Analysis · Geometric least squares mean ratio: 129 · 90% CI 114 to 146A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
PrimaryArea Under the Concentration-time Curve From 0 to Infinity (AUC∞)

AUC 0-∞ is a meausre of total concentration from time zero to infinity

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · ng·hr/mL
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
ng·hr/mLTreatment ATreatment CTreatment ETreatment ITreatment K
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)95.7 (84.5 to 108)192 (169 to 219)121 (97.0 to 150)161 (140 to 184)123 (103 to 146)
Statistical analysis
  • Treatment A vs Treatment E · Mixed Models Analysis · Geometric least squares mean ratio: 161 · 90% CI 139 to 187A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment C vs Treatment E · Mixed Models Analysis · Geometric least squares mean ratio: 159 · 90% CI 135 to 188A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment I vs Treatment K · Mixed Models Analysis · Geometric least squares mean ratio: 131 · 90% CI 116 to 147A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
PrimaryApparent Terminal Half-life (t1/2)

t1/2 is a measure of apparent terminal half-life

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · hr
Apparent Terminal Half-life (t1/2)
hrTreatment ATreatment BTreatment CTreatment DTreatment ETreatment ITreatment JTreatment K
Apparent Terminal Half-life (t1/2)13.6 ± 2.0514.9 ± 1.6914.0 ± 1.7412.9 ± 1.0517.3 ± 1.5414.4 ± 2.7115.8 ± 2.4513.2 ± 2.66
PrimaryMaximum 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

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
ng/mLTreatment ATreatment BTreatment CTreatment DTreatment ITreatment J
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules14.9 (12.5 to 17.8)15.0 (12.6 to 18.0)23.4 (19.3 to 28.2)23.3 (19.2 to 28.3)14.0 (12.1 to 16.3)16.3 (12.9 to 20.7)
Statistical analysis
  • Treatment A vs Treatment B · Mixed Models Analysis · Geometric least squares mean ratio: 99.4 · 90% CI 88.3 to 112A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment C vs Treatment D · Mixed Models Analysis · Geometric least squares mean ratio: 99.9 · 90% CI 85.5 to 117A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment I vs Treatment J · Mixed Models Analysis · Geometric least squares mean ratio: 116 · 90% CI 94.8 to 143A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
PrimaryAUC 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

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · ng·hr/mL
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
ng·hr/mLTreatment ATreatment BTreatment CTreatment DTreatment ITreatment J
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules91.2 (80.6 to 103)99.2 (86.4 to 114)185 (163 to 211)192 (171 to 216)149 (130 to 171)172 (136 to 218)
Statistical analysis
  • Treatment A vs Treatment B · Mixed Models Analysis · Geometric least squares mean ratio: 107 · 90% CI 98.3 to 116A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment C vs Treatment D · Mixed Models Analysis · Geometric least squares mean ratio: 104 · 90% CI 95.0 to 113A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment I vs Treatment J · Mixed Models Analysis · Geometric least squares mean ratio: 115 · 90% CI 95.3 to 140A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
PrimaryAUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules

AUC 0-∞ is a meausre of total concentration from time zero to infinity

Time frame:
Day 1, 5, 9, 13, 17
Reported as:
Geometric mean · ng·hr/mL
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
ng·hr/mLTreatment ATreatment BTreatment CTreatment DTreatment ITreatment J
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules95.7 (84.5 to 108)104 (90.5 to 119)192 (169 to 219)199 (177 to 224)161 (140 to 184)182 (142 to 233)
Statistical analysis
  • Treatment A vs Treatment B · Mixed Models Analysis · Geometric least squares mean ratio: 107 · 90% CI 98.1 to 116A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment C vs Treatment D · Mixed Models Analysis · Geometric least squares mean ratio: 103 · 90% CI 94.6 to 113A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
  • Treatment I vs Treatment J · Mixed Models Analysis · Geometric least squares mean ratio: 113 · 90% CI 93.3 to 137A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.
SecondaryPharmacodynamics (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.

Time frame:
Day -1, 1, 5, 9, 13, 17
Reported as:
Mean · Percent (%) Change
Pharmacodynamics (PD) Profile of RDEA3170
Percent (%) ChangeTreatment ATreatment BTreatment CTreatment DTreatment ETreatment ITreatment JTreatment K
Serum Urate Maximum % Change-29.1 ± 2.05-40.6 ± 1.69-42.5 ± 1.74-52.3 ± 1.05-30.3 ± 1.54-35.2 ± 2.71-46.2 ± 2.45-29.3 ± 2.66
Urine Uric Acid % Change (0-24h)79.2 ± 21.692.3 ± 19.0109 ± 27.888.8 ± 13.676.8 ± 14.449.5 ± 8.2253.7 ± 8.5653.9 ± 10.0
Renal Clearance of Uric Acid % Change (0-24h)137 ± 33.1175 ± 27.2226 ± 48.4216 ± 23.7142 ± 27.1117 ± 17.4153 ± 17.2107 ± 17.7
Fractional Excretion of uric acid % Change (0-24h)119 ± 13.1157 ± 12.9214 ± 14.5214 ± 14.3145 ± 15.1137 ± 18.4168 ± 15.5120 ± 14.2
SecondaryIncidence of Treatment-Emergent Adverse Events
Time frame:
8 weeks
Reported as:
Number · Number of participants
Incidence of Treatment-Emergent Adverse Events
Number of participantsTreatment ATreatment BTreatment CTreatment DTreatment ETreatment ITreatment JTreatmnet K
Incidence of Treatment-Emergent Adverse Events11000220

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment A—0/20 (0%)1/20 (5%)
Treatment B—0/20 (0%)1/20 (5%)
Treatment C—0/20 (0%)0/20 (0%)
Treatment D—0/20 (0%)0/20 (0%)
Treatment E—0/20 (0%)0/20 (0%)
Treatment I—0/15 (0%)2/15 (13.3%)
Treatment J—0/15 (0%)2/15 (13.3%)
Treatment K—0/15 (0%)0/15 (0%)
Most frequent other events
Most frequent other events
EventTreatment ATreatment BTreatment CTreatment DTreatment ETreatment ITreatment JTreatment K
DiarrhoeaGastrointestinal disorders0/200/200/200/200/202/151/150/15
Musculoskeletal StiffnessMusculoskeletal and connective tissue disorders0/200/200/200/200/200/151/150/15
Viral InfectionInfections and infestations1/200/200/200/200/200/150/150/15
HeadacheNervous system disorders0/201/200/200/200/200/150/150/15

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cohort 1Cohort 3 (Optional)Total
Mean35 ± 8.941 ± 12.038 ± 10.45
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Cohort 1Cohort 3 (Optional)Total
Male201535
Female000
Region of Enrollment
Region of Enrollment(Participants)Cohort 1Cohort 3 (Optional)Total
United States201535
08

Study locations

1 site
  • Austin, Texas 78744, United States
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2015 to primary completion in Jun 2015, 1 month.

Results were first posted in Aug 2018, 3 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2015
First posted
May 19, 2015
StartActual
May 1, 2015
Primary completionActual
Jun 26, 2015
CompletionActual
Jan 29, 2016
Results first posted
Aug 20, 2018
Last update
Aug 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02448368
Lead sponsor
Ardea Biosciences, Inc.
Responsible party
Sponsor
First posted
May 19, 2015
Start date
May 1, 2015
Primary completion
Jun 26, 2015
Completion
Jan 29, 2016
Results posted
Aug 20, 2018
Last update
Aug 20, 2018

Study contacts

J Hall, MD
study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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