We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646889
Recruitment Status : Completed
First Posted : November 30, 2020
Last Update Posted : August 5, 2022
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Arthrosi Therapeutics

Tracking Information
First Submitted Date  ICMJE November 18, 2020
First Posted Date  ICMJE November 30, 2020
Last Update Posted Date August 5, 2022
Actual Study Start Date  ICMJE January 14, 2021
Actual Primary Completion Date June 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2020)
  • 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 ]
  • 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 ]
  • Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • 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 ]
  • Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  • Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  • Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  • t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Area under the curve (AUC) for plasma following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • Time to maximum plasma concentration (Tmax) following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • Maximum plasma concentration (Cmax) following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • Terminal half-life (t 1/2) following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • Amount excreted (Ae) into urine following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • Renal clearance (CLr) following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  • AUC for plasma following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  • Tmax following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  • Cmax following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  • t 1/2 following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2020)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function [ Time Frame: 14 days ]
  • Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function [ Time Frame: 21 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment
Official Title  ICMJE A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Impairment
Intervention  ICMJE
  • Drug: AR882 Single Dose
    A single dose of AR882
  • Drug: AR882 Multiple Dose
    AR882 taken once daily for 14 days
Study Arms  ICMJE
  • Experimental: Renal Impairment
    Subjects with various degrees of renal impairment
    Interventions:
    • Drug: AR882 Single Dose
    • Drug: AR882 Multiple Dose
  • Experimental: Normal Renal Function
    Subjects with normal renal function
    Interventions:
    • Drug: AR882 Single Dose
    • Drug: AR882 Multiple Dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2022)
46
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2020)
62
Actual Study Completion Date  ICMJE June 27, 2022
Actual Primary Completion Date June 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT04646889
Other Study ID Numbers  ICMJE AR882-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Arthrosi Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arthrosi Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Iqvia Pty Ltd
Investigators  ICMJE
Study Director: Vijay Hingorani, MD, PhD, MBA Arthrosi Therapeutics
PRS Account Arthrosi Therapeutics
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP