NCT04314986

Brief Summary

A study to assess multiple ascending doses of AR882 in healthy adult males.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
Last Updated

November 16, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 10, 2020

Last Update Submit

November 12, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

  • To evaluate the safety profile of AR882 based on incidence of adverse events

    Incidence of adverse events following multiple doses of AR882

    22 Days

  • To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings

    Incidence of abnormal laboratory findings following multiple doses of AR882

    22 Days

  • To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings

    Incidence of abnormal electrocardiogram findings following multiple doses of AR882

    22 Days

  • To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings

    Incidence of abnormal vital signs findings following multiple doses of AR882

    22 Days

  • Area under the curve (AUC) for plasma AR882

    Profile from plasma in terms of AUC following multiple doses of AR882

    15 Days

  • Time to maximum plasma concentration (Tmax) for AR882

    Profile from plasma in terms of Tmax following multiple doses of AR882

    15 Days

  • Maximum plasma concentration (Cmax) for AR882

    Profile from plasma in terms of Cmax following multiple doses of AR882

    15 Days

  • Apparent terminal half-life (t1/2) for AR882

    Profile from plasma in terms of t1/2 following multiple doses of AR882

    15 Days

  • Amount excreted (Ae) into urine for AR882

    Profile from urine in terms of Ae following multiple doses of AR882

    15 Days

  • Fractional Excretion (FEUA) for AR882

    Profile from urine in terms of FEUA following multiple doses of AR882

    15 Days

Secondary Outcomes (1)

  • PD profile following multiple doses of AR882

    15 Days

Study Arms (5)

AR882 (Dose A)

EXPERIMENTAL
Drug: Cohort 1: AR882 or placebo

AR882 (Dose B)

EXPERIMENTAL
Drug: Cohort 2: AR882 or placebo

AR882 (Dose C)

EXPERIMENTAL
Drug: Cohort 3: AR882 or placebo

AR882 (Dose D)

EXPERIMENTAL
Drug: Cohort 4: AR882 or placebo

Placebo

PLACEBO COMPARATOR
Drug: Cohort 1: AR882 or placeboDrug: Cohort 2: AR882 or placeboDrug: Cohort 3: AR882 or placeboDrug: Cohort 4: AR882 or placebo

Interventions

Cohort 1: AR882 or placeboDRUG

AR882 or matching placebo administered once daily for 10 days

AR882 (Dose A)Placebo
Cohort 2: AR882 or placeboDRUG

AR882 or matching placebo administered once daily for 10 days.

AR882 (Dose B)Placebo
Cohort 3: AR882 or placeboDRUG

AR882 or matching placebo administered once daily for 10 days

AR882 (Dose C)Placebo
Cohort 4: AR882 or placeboDRUG

AR882 or matching placebo administered once daily for 10 days

AR882 (Dose D)Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and \< 9 mg/dL (535 µmol/L)
  • Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
  • Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

You may not qualify if:

  • Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
  • History of cardiac abnormalities
  • History and/or presence of drug addiction or excessive use of alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network Pty, Ltd.

Melbourne, Victoria, 3004, Australia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 19, 2020

Study Start

June 28, 2019

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

November 16, 2020

Record last verified: 2020-03

Locations

AU(1)