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Completed

NCT Number: NCT04646889

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthrosi Investigative Site, Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AR882 Single Dose

Drug

A single dose of AR882

AR882 Multiple Dose

Drug

AR882 taken once daily for 14 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2020
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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