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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

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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: AR882 Single Dose Drug: AR882 Multiple Dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
Actual Study Start Date : January 14, 2021
Actual Primary Completion Date : June 27, 2022
Actual Study Completion Date : June 27, 2022

Arm Intervention/treatment
Experimental: Renal Impairment
Subjects with various degrees of renal impairment
Drug: AR882 Single Dose
A single dose of AR882

Drug: AR882 Multiple Dose
AR882 taken once daily for 14 days

Experimental: Normal Renal Function
Subjects with normal renal function
Drug: AR882 Single Dose
A single dose of AR882

Drug: AR882 Multiple Dose
AR882 taken once daily for 14 days




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  4. 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 ]
  5. Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  6. Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 6 days ]
  7. AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  8. Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  9. Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]
  10. t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646889


Locations
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United States, Florida
Arthrosi Investigative Site
Orlando, Florida, United States, 32809
United States, Texas
Arthrosi Investigative Site
Dallas, Texas, United States, 75230
New Zealand
Arthrosi Investigative Site
Auckland, New Zealand
Arthrosi Investigative Site
Christchurch, New Zealand
Sponsors and Collaborators
Arthrosi Therapeutics
Iqvia Pty Ltd
Investigators
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Study Director: Vijay Hingorani, MD, PhD, MBA Arthrosi Therapeutics
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Responsible Party: Arthrosi Therapeutics
ClinicalTrials.gov Identifier: NCT04646889    
Other Study ID Numbers: AR882-104
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases