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History of Changes for Study: NCT04646889
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment
Latest version (submitted August 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 27, 2020 None (earliest Version on record)
2 December 19, 2020 Arms and Interventions, Outcome Measures and Study Status
3 January 20, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 March 13, 2021 Contacts/Locations and Study Status
5 November 8, 2021 Contacts/Locations and Study Status
6 July 18, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 August 3, 2022 Study Status
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Study NCT04646889
Submitted Date:  November 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: AR882-104
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: December 2020
Primary Completion: September 2021 [Anticipated]
Study Completion: September 2021 [Anticipated]
First Submitted: November 18, 2020
First Submitted that
Met QC Criteria:
November 27, 2020
First Posted: November 30, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 27, 2020
Last Update Posted: November 30, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Arthrosi Therapeutics
Responsible Party: Sponsor
Collaborators: Iqvia Pty Ltd
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Renal Impairment
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 62 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Renal Impairment
Subjects with various degrees of renal impairment
Drug: AR882 100 mg
A single dose of AR882 100 mg
Drug: AR882 75 mg
AR882 75 mg taken once daily for 14 days
Experimental: Normal Renal Function
Subjects with normal renal function
Drug: AR882 100 mg
A single dose of AR882 100 mg
Drug: AR882 75 mg
AR882 75 mg taken once daily for 14 days
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

2. 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 ]

3. 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 ]

4. 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 ]

5. 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 ]

6. Renal clearance (CLr) following a single dose of AR882 100 mg in subjects with renal impairment and normal renal function
[ Time Frame: 6 days ]

7. AUC for plasma following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function
[ Time Frame: 15 days ]

8. Tmax following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function
[ Time Frame: 15 days ]

9. Cmax following multiple doses of AR882 75 mg in subjects with renal impairment and normal renal function
[ Time Frame: 15 days ]

10. t 1/2 following multiple doses of AR882 75 mg 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 100 mg 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 75 mg in subjects with renal impairment and normal renal function
[ Time Frame: 21 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Central Contact Person: Director, Clinical Operations
Telephone: (949) 393-2676
Email: info@arthrosi.com
Study Officials: Vijay Hingorani, MD, PhD, MBA
Study Director
Arthrosi Therapeutics
Locations: United States, Florida
Arthrosi Investigative Site
Orlando, Florida, United States, 32809
Australia, Perth
Arthrosi Investigative Site
Nedlands, Perth, Australia
New Zealand
Arthrosi Investigative Site
Christchurch, New Zealand
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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