Clinical trial NCT04646889: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2020-11-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
timeFrame: 6 days
measure: Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
timeFrame: 6 days
measure: Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
timeFrame: 6 days
measure: Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
timeFrame: 6 days
measure: Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
timeFrame: 6 days
measure: Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
timeFrame: 6 days
measure: AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
timeFrame: 15 days
measure: Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
timeFrame: 15 days
measure: Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
timeFrame: 15 days
measure: t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
timeFrame: 15 days
Secondary outcomes:
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 21 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Arthrosi Investigative Site
state: Florida
city: Dallas
country: United States
facility: Arthrosi Investigative Site
state: Texas
city: Auckland
country: New Zealand
facility: Arthrosi Investigative Site
city: Christchurch
country: New Zealand
facility: Arthrosi Investigative Site
Study officials:
affiliation: Arthrosi Therapeutics
name: Vijay Hingorani, MD, PhD, MBA
role: STUDY_DIRECTOR
References: