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Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AR882 Single Dose

AR882 Multiple Dose

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All Subjects:

Males and non-pregnant, non-lactating females
Body weight no less than 50 kg
sUA greater than or equal to 4.0 mg/dL

Renal Impaired Subjects:

• History of chronic renal impairment (> 6 months)

Exclusion Criteria:

All Subjects:

Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
History of cardiac abnormalities
Active peptic ulcer disease or active liver disease
History of kidney stones

Renal Impaired Subjects:

• Requires dialysis

Sites / Locations

Arthrosi Investigative Site
Arthrosi Investigative Site
Arthrosi Investigative Site
Arthrosi Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Renal Impairment

Normal Renal Function

Arm Description

Subjects with various degrees of renal impairment

Subjects with normal renal function

Outcomes

Primary Outcome Measures

Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function

Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function

Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function

Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function

Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function

Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function

AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function

Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function

Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function

t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function

Secondary Outcome Measures

Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function

Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function

Full Information

NCT ID

NCT04646889

First Posted

November 18, 2020

Last Updated

August 3, 2022

Sponsor

Arthrosi Therapeutics

Collaborators

Iqvia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04646889

Brief Title

Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

Official Title

A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 14, 2021 (Actual)

Primary Completion Date

June 27, 2022 (Actual)

Study Completion Date

June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arthrosi Therapeutics

Collaborators

Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Renal Impairment

Arm Type

Experimental

Arm Description

Subjects with various degrees of renal impairment

Arm Title

Normal Renal Function

Arm Type

Experimental

Arm Description

Subjects with normal renal function

Intervention Type

Drug

Intervention Name(s)

AR882 Single Dose

Intervention Description

A single dose of AR882

Intervention Type

Drug

Intervention Name(s)

AR882 Multiple Dose

Intervention Description

AR882 taken once daily for 14 days

Primary Outcome Measure Information:

Title

Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

6 days

Title

Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

6 days

Title

Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

6 days

Title

Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

6 days

Title

Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

6 days

Title

Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

6 days

Title

AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function

Time Frame

15 days

Title

Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function

Time Frame

15 days

Title

Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function

Time Frame

15 days

Title

t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function

Time Frame

14 days

Title

Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All Subjects: Males and non-pregnant, non-lactating females Body weight no less than 50 kg sUA greater than or equal to 4.0 mg/dL Renal Impaired Subjects: • History of chronic renal impairment (> 6 months) Exclusion Criteria: All Subjects: Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin History of cardiac abnormalities Active peptic ulcer disease or active liver disease History of kidney stones Renal Impaired Subjects: • Requires dialysis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vijay Hingorani, MD, PhD, MBA

Organizational Affiliation

Arthrosi Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Arthrosi Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Arthrosi Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Arthrosi Investigative Site

City

Auckland

Country

New Zealand

Facility Name

Arthrosi Investigative Site

City

Christchurch

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

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Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

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