NCT04646889

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

November 18, 2020

Last Update Submit

August 3, 2022

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (10)

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

    6 days

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

    6 days

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

    6 days

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

    6 days

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

    6 days

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

    6 days

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

    15 days

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

    15 days

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

    15 days

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

    15 days

Secondary Outcomes (2)

  • 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

    14 days

  • 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

    21 days

Study Arms (2)

Renal Impairment

EXPERIMENTAL

Subjects with various degrees of renal impairment

Drug: AR882 Single DoseDrug: AR882 Multiple Dose

Normal Renal Function

EXPERIMENTAL

Subjects with normal renal function

Drug: AR882 Single DoseDrug: AR882 Multiple Dose

Interventions

AR882 Single DoseDRUG

A single dose of AR882

Normal Renal FunctionRenal Impairment
AR882 Multiple DoseDRUG

AR882 taken once daily for 14 days

Normal Renal FunctionRenal Impairment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arthrosi Investigative Site

Orlando, Florida, 32809, United States

Location

Arthrosi Investigative Site

Dallas, Texas, 75230, United States

Location

Arthrosi Investigative Site

Auckland, New Zealand

Location

Arthrosi Investigative Site

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Vijay Hingorani, MD, PhD, MBA

    Arthrosi Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 30, 2020

Study Start

January 14, 2021

Primary Completion

June 27, 2022

Study Completion

June 27, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)NZ(2)