The Phase 1 New Zealand Renal Trial with RVX-208 (aka apabetalone, RVX000222) is listed on the Australian New Zealand Clinical Trial Registry. If this link doesn't work, search the registry for "Resverlogix" and you'll find it. I've copied some of the highlights below. Enrollment was anticipated to begin June 1, 2016 and enrollment be completed September 2, 2016. It is currently listed as not yet recruiting. However, in Monday's webcast Don mentioned something to the effect that the trial would be launching this week.

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.

Brief summary: RVX000222 is being developed to prevent major heart events in individuals at high risk of heart disease.

RVX000222 is mainly cleared from the body by the liver, with only a small amount of each dose cleared by the kidneys. The study team wants to confirm this by comparing how RVX000222 is processed and cleared by the body,in adults with severely reduced kidney function and in adults whose kidneys are working normally. The study will also collect information about how safe and well tolerated RVX000222 is.

Two groups will be enrolled for the study:

Group 1: approximately 8 adults with severely reduced kidney function, and

Group 2: approximately 8 adults with normal kidney function.

Each participant in Group 2 will be selected as a 'match' for a Group 1 participant, based on age, weight, and gender.

Every person in the study will take a single 100 mg dose of RVX000222, by mouth, on Day 1 of the study only.

Levels of the study drug and its breakdown products will be measured in blood and urine samples collected at specific times after dosing, and any changes in health will be recorded.

The results will provide important information about whether the dose of RVX000222 needs to be adjusted when used by patients with reduced kidney function.

Trial ID: ACTRN12616000642482

Secondary ID: Protocol Number: RVX222-CS-016

Universal Trial Number (UTN): U1111-1182-3664

Phase: Phase 1

Type of endpoint(s): Pharmacokinetics

Anticipated date of first participant enrolment: 1/06/2016

Anticipated date last participant enrolled: 2/09/2016

Target sample size: 16

Recruitment status: Not yet recruiting

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.

Primary outcome [1]: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]- 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]: 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]- 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]: 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]Blood samples for measurement of biomarkers in plasma would be collected on Day 1, Day 2 and Day 3.