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Trial registered on ANZCTR


Registration number
ACTRN12616000642482
Ethics application status
Approved
Date submitted
10/05/2016
Date registered
18/05/2016
Date last updated
20/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing how fast the trial drug RVX000222 is cleared from the body, in healthy adults and in adults with severely reduced kidney function.
Scientific title
A Phase I, Open-Label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of a Single Oral Dose of RVX000222 in Subjects with Severe Renal Impairment.
Secondary ID [1] 289105 0
Protocol Number: RVX222-CS-016
Universal Trial Number (UTN)
U1111-1182-3664
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe renal impairment. 298564 0
Condition category
Condition code
Renal and Urogenital 298646 298646 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be an open-label, parallel group clinical study to evaluate the safety and Pharmacokinetics of a single 100 mg oral dose of RVX000222 in subjects with renal impairment and age-, weight-, and gender- matched healthy subjects.

Two Cohorts of eight (8) subjects will be enrolled in the study:
- Cohort 1: approximately eight (8) subjects with severe renal impairment, and
- Cohort 2: approximately eight (8) healthy control subjects.
Each participant in Cohort 2 will be selected as a 'match' for a Cohort 1 participant, based on age, weight, and gender.

Each participant in the study will receive a single oral administration of the study drug, RVX000222 100mg capsule.
Intervention code [1] 294608 0
Treatment: Drugs
Comparator / control treatment
Eight (8) healthy control subjects, age-, gender- and weight- matched to eight (8) End Stage Renal Disease (ESRD) subjects.
Control group
Active

Outcomes
Primary outcome [1] 298141 0
To assess the safety and tolerability of single oral administration of RVX000222 in subjects with severe renal impairment.
Method of assessment: vital signs, physical examination, 12-lead electrocardiograms (ECG), clinical laboratory tests and adverse events.
Timepoint [1] 298141 0
- Vital signs would be at Screening, Day -1, Day 1 , Day 2, Day 3 and Day 7.
- Physical examination would be at Screening, Day -1, Day 3 and Day 7.
- 12-lead Electrocardiograms (ECG) would be at Screening and Day 7.
- Clinical laboratory tests would be collected at Screening, Day -1, Day 2, Day 3 and Day 7.
- All Adverse Events will be collected from Screening to Day 7.
Primary outcome [2] 298274 0
To assess the pharmacokinetics (PK) of single oral administration of RVX000222 in subjects with severe renal impairment.
Method of assessment: PK blood and urine sampling.
Timepoint [2] 298274 0
- PK blood samples would be collected at Day 1, Day 2, Day 3 and Day 7.
- PK urine samples would be collected at Day 1, Day 2 and Day 3.
Secondary outcome [1] 323261 0
The exploratory objective of the study is to evaluate acute changes in biomarker relevant to Bromodomain Extra Terminal (BET) inhibition. A proteomic analysis involving 1300 protein markers will be conducted. The analysis will be conducted using the SOMAscan assay and reagents offered by SomaLogic (http://www.somalogic.com/About-Us.aspx).
Timepoint [1] 323261 0
Blood samples for measurement of biomarkers in plasma would be collected on Day 1, Day 2 and Day 3.

Eligibility
Key inclusion criteria
1. Male or female between 18 and 80 years old, inclusive;
2. If female, have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, or meet at least one of the following criteria: post-surgical sterilization or two years postmenopausal.
3. If subject is female of childbearing potential, subject must be willing to practice an acceptable non-hormonal method of birth control from Day 1 through until at least 30 days post study drug administration (e.g., abstinence);
4. Provide written informed consent before participation in the study;
5. Stable renal function, in the opinion of the Investigator, for at least 3 months prior to Screen visit.

Cohort 1: Renal Impairment Subjects:
6. Previously diagnosed with ESRD and not on dialysis (eGFR <30 mL/min/1.73m2).

Cohort 2: Healthy Subjects:
7. Healthy volunteers matched for age (plus or minus 10 years), weight (plus or minus 20%), and gender with the subjects in Cohort 1 (renal impaired subjects);
8. eGFR greater than or equal to 60 mL/min/1.73m2).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently undergoing renal dialysis;
2. Have donated blood or plasma, in excess of 500 mL. during the 30-day period before Day -1;
3. History of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin;
4. Evidence of cirrhosis from liver imaging or biopsy, history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure, or a Child-Pugh score of at least 5 points;
5. Have active cholecystitis or gallbladder symptoms within 60 days before Day -1 (subjects who have had a cholecystectomy are not excluded from this study);
6. Type 2 diabetes mellitus with unstable disease or changes in therapy (30) days prior to Day -1 (clinical trial unit admission) may be excluded, as determined by the investigator and/or medical monitor;
7. Have a screening 12-lead ECG considered clinically significant by the investigator;
8. Body Mass Index (BMI) >40 kg/m2;
9. Have positive test results for, or evidence of active infection with human immunodeficiency virus type 1 or 2, hepatitis A, B, or C;
10. Hormonal contraceptives are not allowed during study participation by study subjects from Visit 1/Screen until 48 hours post study drug administration. Subjects who take hormone replacement therapy must be willing to discontinue their hormonal therapy if it is medically appropriate;
11. Current or recent (within 12 months prior to Screen) use of systemic immunosuppressants, including but not limited to, corticosteroids (prednisone equivalent of >20 mg/day for >2 weeks), azathioprine, or cyclosporine;
12. Use of strong inhibitors or inducers of CYP3A4/5, OATP1B1, and OAT1/3 within 30 days of five half-lives, whichever is longer, prior to Day -1 (clinical research unit admission) and during the study (e.g. Boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazone, opinvir/rionavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinarir, telaprevir, telithromycin, voriconazole, rifampin, carbamazepine, phenytoin, or probenecid);
13. Use of diclofenac or clavulanic acid from 7 days prior to Day 1 (treatment day) and during the study;
14. Use of >1.0g acetaminophen from Day -1 (clinical research unit admission) to Day 1 (treatment day);
15. Have consumed grapefruit juice within 7 days before Day -1 to 48 hours post study drug administration;
16. Have any known allergy or intolerance to any compound in RVX000222 or any other closely related compound;
17. Are unwilling to abstain from alcoholic beverages, caffeine or xanthine-containing products, and use of nicotine products during the clinical research unit confinement period;
18. Have a positive result on drugs of abuse screen testing (Screen and Day -1). If a subject tests positive for a drug of abuse, and has a current prescription for the drug to treat a defined indication, the subject may be eligible for the participation;
19. Alanine transaminase (ALT) or Aspartate transaminase (AST) >2.0 x upper limit of normal (ULN) at Screen;
20. Total bilirubin >1.5 x upper limit of normal at Screen;
21. Have participated in a clinical study and received any investigational medication within the last 30 days or five half-lives, whichever is long, preceding Day -1;
22. In the opinion of the investigator, are not able or willing to comply with the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2016
Actual
19/07/2016
Date of last participant enrolment
Anticipated
2/09/2016
Actual
10/09/2016
Date of last data collection
Anticipated
16/09/2016
Actual
16/09/2016
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 7846 0
New Zealand
State/province [1] 7846 0
Christchurch

Funding & Sponsors
Funding source category [1] 293491 0
Commercial sector/Industry
Name [1] 293491 0
Resverlogix Corp
Country [1] 293491 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
CPR Pharma Services Pty Ltd
Address
c/o Infinity Consulting Ltd
PO Box 105 239
Auckland City 1143
Country
New Zealand
Secondary sponsor category [1] 292315 0
Commercial sector/Industry
Name [1] 292315 0
Resverlogix Corp
Address [1] 292315 0
300, 4820 Richard Road SW
Calgary, AB, T3E 6L1
Country [1] 292315 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294934 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 294934 0
Ethics committee country [1] 294934 0
New Zealand
Date submitted for ethics approval [1] 294934 0
04/05/2016
Approval date [1] 294934 0
24/05/2016
Ethics approval number [1] 294934 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65478 0
Dr Richard Robson
Address 65478 0
Christchurch Clinical Studies Trust Ltd (CCST)
PO Box 2856
Christchurch 8140
Country 65478 0
New Zealand
Phone 65478 0
+64 3 372 9477
Fax 65478 0
Email 65478 0
richard@ccst.co.nz
Contact person for public queries
Name 65479 0
Devonie Waaka
Address 65479 0
Christchurch Clinical Studies Trust Ltd (CCST)
PO Box 2856
Christchurch 8140
Country 65479 0
New Zealand
Phone 65479 0
+64 3 372 9477
Fax 65479 0
Email 65479 0
devonie@ccst.co.nz
Contact person for scientific queries
Name 65480 0
Michael Sweeney
Address 65480 0
Resverlogix Corp.
300, 4820 Richard Road SW
Calgary, AB, T3E 6L1
Country 65480 0
Canada
Phone 65480 0
+1 415 470 5613
Fax 65480 0
Email 65480 0
clinicaltrials@resverlogix.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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