A Phase 1 interventional study of RDEA3170 10 mg and RDEA3170 2.5 mg in Gout, 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 2017-10-13.
Sponsored by Ardea Biosciences, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Basic science
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 27 studies in Gout by AstraZeneca — none open to participants now, none under way, none of them phase 3. Gout · AstraZeneca.
Among the 27 studies in Gout by AstraZeneca, this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 7 that started in 2014, is one of 9 in phase 1, and was the 20th registered.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
Browse Gout studies →None of the 27 studies in Gout by AstraZeneca is open now. The open studies under Gout, anywhere →
Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 65 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 7 · Phase 3 7 · Phase 4 1
First in 2008; this study’s year is marked. 7 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 83 across 286 interventional studies indexed under Gout.
Median enrollment 87 across the 24 interventional studies, 223 across the 3 observational. Of the 26 that completed or were terminated, 14 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Ardea Biosciences, Inc., one of the names counted as AstraZeneca. Under that name alone:
Ardea Biosciences, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Gout by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: RDEA3170 10 mg · Drug: RDEA3170 2.5 mg
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
Drug: RDEA3170 10 mg · Drug: RDEA3170 2.5 mg
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
Drug: RDEA3170 10 mg · Drug: RDEA3170 2.5 mg
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
Drug: RDEA3170 10 mg · Drug: RDEA3170 2.5 mg
Maximum Observed Plasma Concentration (Cmax)
Cmax of RDEA3170 in fasted condition.
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.
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax of RDEA3170 following various treatments.
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.
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
AUC last of RDEA3170 in fasted condition.
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.
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
AUC∞ of RDEA3170 the fasted condition.
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.
Apparent Terminal Half-life (t1/2)
t1/2 of RDEA3170 following various treatments.
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: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Cmax of RDEA3170 in high-fat fed state.
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: Effect of High Fat Meal on the PK of RDEA3170 Tablets
AUC last of RDEA3170 in high-fat fed state.
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∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
AUC∞ of RDEA3170 in high-fat fed state.
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: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Cmax of RDEA3170 in low-fat fed state.
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: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
AUC last of RDEA3170 in low-fat fed state.
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∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
AUC∞ of RDEA3170 in low-fat fed state.
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.
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.
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.
15 subjects were randomized
| Milestone | Sequence ABCD | Sequence BACD | Sequence ABDC | Sequence BADC |
|---|---|---|---|---|
| Started | 3 | 4 | 4 | 4 |
| Completed | 3 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
Cmax of RDEA3170 in fasted condition.
| ng/mL | Treatment A | Treatment B |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 14.1 (11.7 to 16.8) | 14.9 (11.9 to 18.8) |
Tmax of RDEA3170 following various treatments.
| hr | Treatment A | Treatment B | Treatment C | Treatment D |
|---|---|---|---|---|
| Time of Occurrence of Maximum Observed Concentration (Tmax) | 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) |
AUC last of RDEA3170 in fasted condition.
| ng·hr/mL | Treatment A | Treatment B |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | 119 (96.8 to 146) | 114 (85.7 to 153) |
AUC∞ of RDEA3170 the fasted condition.
| ng·hr/mL | Treatment A | Treatment B |
|---|---|---|
| Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | 131 (105 to 164) | 130 (95.9 to 176) |
t1/2 of RDEA3170 following various treatments.
| hr | Treatment A | Treatment B | Treatment C | Treatment D |
|---|---|---|---|---|
| Apparent Terminal Half-life (t1/2) | 16.5 (11.6 to 23.4) | 15.5 (10.6 to 22.5) | 15.4 (11.6 to 20.4) | 16.6 (11.5 to 23.9) |
Cmax of RDEA3170 in high-fat fed state.
| ng/mL | Treatment B | Treatment D |
|---|---|---|
| Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets | 14.9 (11.9 to 18.8) | 27.2 (20.2 to 36.6) |
AUC last of RDEA3170 in high-fat fed state.
| ng·hr/mL | Treatment B | Treatment D |
|---|---|---|
| AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets | 114 (85.7 to 153) | 160 (130 to 199) |
AUC∞ of RDEA3170 in high-fat fed state.
| ng·hr/mL | Treatment B | Treatment D |
|---|---|---|
| AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets | 130 (95.9 to 176) | 173 (137 to 219) |
Cmax of RDEA3170 in low-fat fed state.
| ng/mL | Treatment B | Treatment C |
|---|---|---|
| Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets | 14.9 (11.9 to 18.8) | 11.8 (9.23 to 15.1) |
AUC last of RDEA3170 in low-fat fed state.
| ng·hr/mL | Treatment B | Treatment C |
|---|---|---|
| AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets | 114 (85.7 to 153) | 97.8 (77.3 to 124) |
AUC∞ of RDEA3170 in low-fat fed state.
| ng·hr/mL | Treatment B | Treatment C |
|---|---|---|
| AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets | 130 (95.9 to 176) | 108 (84.4 to 139) |
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.
| Percent | Treatment A | Treatment B | Treatment C | Treatment D |
|---|---|---|---|---|
| Serum Urate Maximum % Change | -34.4 ± 2.08 | -34.4 ± 2.27 | -37.3 ± 1.89 | -49.0 ± 1.96 |
| Urine Uric Acid % Change(0-24h) | 96.6 ± 12.5 | 78.5 ± 8.38 | 53.4 ± 8.85 | 65.9 ± 9.70 |
| Renal Clearance of Uric Acid % Change (0-24h) | 170 ± 19.5 | 147 ± 15.6 | 128 ± 18.9 | 179 ± 21.5 |
| Fractional Excretion of Uric Acid % Change (0-24h) | 159 ± 15.1 | 151 ± 22.0 | 149 ± 22.7 | 199 ± 23.2 |
| Number of Participants | Treatment A | Treatment B | Treatment C | Treatment D |
|---|---|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 0 | 1 | 1 | 3 |
Collected over 7 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | — | 0/15 (0%) | 0/15 (0%) |
| Treatment B | — | 0/15 (0%) | 1/15 (6.7%) |
| Treatment C | — | 0/15 (0%) | 1/15 (6.7%) |
| Treatment D | — | 0/15 (0%) | 3/15 (20%) |
| Event | Treatment A | Treatment B | Treatment C | Treatment D |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/15 | 0/15 | 1/15 | 2/15 |
| NauseaGastrointestinal disorders | 0/15 | 1/15 | 0/15 | 0/15 |
| PeriarthritisMusculoskeletal and connective tissue disorders | 0/15 | 0/15 | 0/15 | 1/15 |
| HeadacheNervous system disorders | 0/15 | 1/15 | 0/15 | 0/15 |
| Age, Continuous(Years) | Sequence ABCD | Sequence BACD | Sequence ABDC | Sequence BADC | Total |
|---|---|---|---|---|---|
| Mean | 51 ± 9.8 | 39 ± 9.7 | 40 ± 12.3 | 42 ± 16.0 | 42 ± 11.9 |
| Age, Customized(Participants) | Sequence ABCD | Sequence BACD | Sequence ABDC | Sequence BADC | Total |
|---|---|---|---|---|---|
| <65 | 3 | 4 | 4 | 4 | 15 |
| >=65 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sequence ABCD | Sequence BACD | Sequence ABDC | Sequence BADC | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 3 | 4 | 4 | 4 | 15 |
| Region of Enrollment(Participants) | Sequence ABCD | Sequence BACD | Sequence ABDC | Sequence BADC | Total |
|---|---|---|---|---|---|
| United States | 3 | 4 | 4 | 4 | 15 |
The record gives a start of Nov 2014, a primary completion of Jan 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2017, 2 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Verinurad