Gout. MedDRA version: 12.0 Level: LLT Classification code 10018627 Term: Gout
Conditions
Interventions
Product Name: RDEA594
Product Code: RDEA594
Pharmaceutical Form: Capsule, hard
CAS Number: 1151516-14-1
Current Sponsor code: RDEA594
Other descriptive name: RDEA594 Sodium
Concentration unit: mg mill
Sponsors
Ardea Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject is an adult male or non-reproductive (post-menopausal or surgically sterile) female. Postmenopausal is generally defined as a period of twelve (12) consecutive months of amenorrhoea. In women under 55 years of age whose menopausal status is in question, a follicle-stimulating hormone (FSH) level of >40 mIU/mL or an oestrogen deficiency of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject requires dialysis for treatment of renal disease. 2.Subject has a gout flare at screening that is resolved for less than one week prior to the first administration of study drug (exclusive of chronic synovitis/arthritis). 3.Subject has documented history of, or suspicion of kidney stones. 4.Subject has received any investigational drug within 2 months prior to study drug dosing. 5.Subject has received a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing due to potential interactions with colchicine. 6.Subject reports receiving any enzyme-inducing drug or product within 2 months prior to study drug dosing. 7.Subject has uncontrolled hypertension, a clinically relevant abnormality in blood pressure (BP), heart rate (HR), body temperature, or respiratory rate as per the Investigator’s judgment as follows: a.Systolic BP 190 mmHg in supine position b.Diastolic BP 110 mmHg in supine position c.Heart rate 100 bpm in supine position d.Body temperature 37.5°C e.Respiratory rate 20 bpm 8.Subject has used medications that prolong the QT/QTc interval within 14 days prior to Day 1 dosing 9.Subject has a history of clinically significant health problems or diseases unrelated to the patient’s renal insufficiency as determined by the clinical investigator(s). Patients with disorders related to renal insufficiency may be enrolled if in the investigator’s judgment the disorder will not compromise patient safety or study objectives 10.Subject has a serum ALT or AST that exceeds 2.5 times the upper limit of normal. 11.Subject has presence or history of cardiac abnormalities including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate 140 milliseconds (msec), symptomatic arrhythmias, heart failure, hypokalemia, family history of Long QT Syndrome, family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years 12.Subject has a QTcB interval (QT interval corrected for heart rate according to Bazett) > 470 msec for males and > 490 msec for females at Screening, on Day –1 or pre-dose on Day 1. 13.Subject has undergone major surgery within 3 months of Day 1. 14.Subject has a confirmed reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody. Positive hepatitis C antibody to be confirmed by PCR. 15.Subject has uncontrolled Diabetes Mellitus, metabolic syndrome, or chronic diarrhea. 16.Subject has a clinically significant illness during the 7 days prior to day 1 study drug dosing (as determined by the clinical investigator) 17.Subject demonstrates a positive drug screen (cocaine, cannabis, amphetamine, opiate) or alcohol screen at screening or check-in (Day -1), with the exception of prescription drugs 18.Subject has a known hypersensitivity or allergy to RDEA594, allopurinol, colchicine, or any components in their formulations 19.Subject has a history of clinically significant allergies including food or drug allergies 20.Subject reports a history (within the past 12 months) or presence of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units of alcohol; one unit of alcohol equals ½ a pint of beer or lager, a glass of wine or a measure of spirits) 21.Subject has donat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety profile of orally administered RDEA594 alone or as an add-on to ongoing allopurinol treatment in gout patients with moderate renal insufficiency. ;Primary end point(s): To determine the safety profile of orally administered RDEA594 alone or as an add-on to ongoing allopurinol treatment in gout patients with moderate renal insufficiency. ;Secondary Objective: •To evaluate the pharmacokinetics of RDEA594 in gout patients with moderate renal insufficiency. •To evaluate the pharmacokinetic interaction between RDEA594 and allopurinol/oxypurinol and between RDEA594 and colchicine in gout patients with moderate renal insufficiency. •To evaluate the uricosuric effects of orally administered RDEA594 alone or as an add-on to ongoing allopurinol treatment in gout patients with moderate renal insufficiency. | — |
Countries
Belgium
Outcome results
None listed