Healthy VolunteersPhase 1NCT04347005
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
A Phase 1 study testing Cohort 1: AR882, Cohort 2: AR882 and Cohort 3: AR882 in people with Healthy Volunteers, run by Arthrosi Therapeutics at 1 site in Australia.
Trial summary
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cohort 1: AR882, Cohort 2: AR882 and Cohort 3: AR882
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Jan 2019to 31 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Serum uric acid level ≥ 4.5 mg/dL (268 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
- Conditions
- Healthy Volunteers
- Being tested
- Cohort 1: AR882, Cohort 2: AR882, Cohort 3: AR882, Cohort 4: AR882, Cohort 5: AR882
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: AR882Drug
Single dose of AR882 or matching placebo
Cohort 2: AR882Drug
Single dose of AR882 or matching placebo
Cohort 3: AR882Drug
Single dose of AR882 or matching placebo
Cohort 4: AR882Drug
Single dose of AR882 or matching placebo
Cohort 5: AR882Drug
Single dose of AR882 or matching placebo
Cohort 6: AR882 Food EffectDrug
Single dose of AR882 or matching placebo in a fed state
Cohort 7: AR882 Solid Oral FormulationDrug
Single dose of AR882 or matching placebo
Cohort 8: AR882 in combination with allopurinolDrug
Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol
Cohort 9: AR882 in combination with febuxostatDrug
Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
| Study group | Role | What they receive |
|---|---|---|
| AR882 (Dose A) | Experimental | Not described Receives: Drug: Cohort 1: AR882 |
| AR882 (Dose B) | Experimental | Not described Receives: Drug: Cohort 2: AR882; Drug: Cohort 6: AR882 Food Effect; Drug: Cohort 8: AR882 in combination with allopurinol; Drug: Cohort 9: AR882 in combination with febuxostat |
| AR882 (Dose C) | Experimental | Not described Receives: Drug: Cohort 3: AR882 |
| AR882 (Dose D) | Experimental | Not described Receives: Drug: Cohort 4: AR882 |
| AR882 (Dose E) | Experimental | Not described Receives: Drug: Cohort 5: AR882 |
| AR882 (Dose B) Solid Oral Formulation | Experimental | Not described Receives: Drug: Cohort 7: AR882 Solid Oral Formulation |
| Placebo | Placebo comparator | Not described Receives: Drug: Cohort 1: AR882; Drug: Cohort 2: AR882; Drug: Cohort 3: AR882; Drug: Cohort 4: AR882; Drug: Cohort 5: AR882; Drug: Cohort 6: AR882 Food Effect; Drug: Cohort 7: AR882 Solid Oral Formulation |
| Allopurinol | Active comparator | Not described Receives: Drug: Cohort 8: AR882 in combination with allopurinol |
| Febuxostat | Active comparator | Not described Receives: Drug: Cohort 9: AR882 in combination with febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Analysis of abnormal safety laboratory findings
Measured: 8 Days
Safety Analyses
ECG Heart Rate
Measured: 8 Days
Safety Analyses
ECG PR-Interval
Measured: 8 Days
Safety Analyses
ECG RR-Interval
Measured: 8 Days
Safety Analyses
ECG QRS-Interval
Measured: 8 Days
Safety Analyses
ECG QT-Interval
Measured: 8 Days
Safety Analyses
ECG QTc-Interval
Measured: 8 Days
Safety Analyses
Vital Sign - Systolic Blood Pressure
Measured: 8 Days
Safety Analyses
Vital Sign - Diastolic Blood Pressure
Measured: 8 Days
Safety Analyses
Vital Sign - Pulse Rate
Measured: 8 Days
Safety Analyses
Vital Sign - Body Temperature
Measured: 8 Days
Safety Analyses
Vital Sign - Respiratory Rate
Measured: 8 Days
Area under the curve (AUC) for plasma AR882
Profile from plasma in terms of AUC for AR882
Measured: 6 Days
Time to maximum plasma concentration (Tmax) for AR882
Profile from plasma in terms of Tmax for AR882
Measured: 6 Days
Maximum plasma concentration (Cmax) for AR882
Profile from plasma in terms of Cmax for AR882
Measured: 6 Days
Apparent terminal half-life (t1/2) for AR882
Profile from plasma in terms of t1/2 for AR882
Measured: 6 Days
Amount excreted (Ae) into urine for AR882
Profile from urine in terms of Ae for AR882
Measured: 6 Days
Fractional Excretion (FEUA) for AR882
Profile from urine in terms of FEUA for AR882
Measured: 6 Days
Secondary outcomes (3)
PD profile of a single dose of AR882
Profile from serum uric acid concentrations over time
Measured: 6 Days
PD profile of a single dose of AR882 in combination with allopurinol
Profile from serum uric acid concentrations over time
Measured: 6 Days
PD profile of a single dose of AR882 in combination with febuxostat
Profile from serum uric acid concentrations over time
Measured: 6 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start22 Jan 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347005
- Sponsor's protocol ID
- AR882-101
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT04347005
- Acronym / sponsor ID
- AR882-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| AR882 (Dose A) | Experimental | Drug: Cohort 1: AR882 |
| AR882 (Dose B) | Experimental | Drug: Cohort 2: AR882, Drug: Cohort 6: AR882 Food Effect, Drug: Cohort 8: AR882 in combination with allopurinol, Drug: Cohort 9: AR882 in combination with febuxostat |
| AR882 (Dose C) | Experimental | Drug: Cohort 3: AR882 |
| AR882 (Dose D) | Experimental | Drug: Cohort 4: AR882 |
| AR882 (Dose E) | Experimental | Drug: Cohort 5: AR882 |
| AR882 (Dose B) Solid Oral Formulation | Experimental | Drug: Cohort 7: AR882 Solid Oral Formulation |
| Placebo | Placebo comparator | Drug: Cohort 1: AR882, Drug: Cohort 2: AR882, Drug: Cohort 3: AR882, Drug: Cohort 4: AR882, Drug: Cohort 5: AR882, Drug: Cohort 6: AR882 Food Effect, Drug: Cohort 7: AR882 Solid Oral Formulation |
| Allopurinol | Active comparator | Drug: Cohort 8: AR882 in combination with allopurinol |
| Febuxostat | Active comparator | Drug: Cohort 9: AR882 in combination with febuxostat |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Serum uric acid level ≥ 4.5 mg/dL (268 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1: AR882Single dose of AR882 or matching placebo | Drug | AR882 (Dose A), Placebo |
| Cohort 2: AR882Single dose of AR882 or matching placebo | Drug | AR882 (Dose B), Placebo |
| Cohort 3: AR882Single dose of AR882 or matching placebo | Drug | AR882 (Dose C), Placebo |
| Cohort 4: AR882Single dose of AR882 or matching placebo | Drug | AR882 (Dose D), Placebo |
| Cohort 5: AR882Single dose of AR882 or matching placebo | Drug | AR882 (Dose E), Placebo |
| Cohort 6: AR882 Food EffectSingle dose of AR882 or matching placebo in a fed state | Drug | AR882 (Dose B), Placebo |
| Cohort 7: AR882 Solid Oral FormulationSingle dose of AR882 or matching placebo | Drug | AR882 (Dose B) Solid Oral Formulation, Placebo |
| Cohort 8: AR882 in combination with allopurinolSingle dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol | Drug | AR882 (Dose B), Allopurinol |
| Cohort 9: AR882 in combination with febuxostatSingle dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat | Drug | AR882 (Dose B), Febuxostat |
Primary outcome
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Time frame: 8 Days
Analysis of abnormal safety laboratory findings
Safety Analyses
Time frame: 8 Days
ECG Heart Rate
Safety Analyses
Time frame: 8 Days
ECG PR-Interval
Safety Analyses
Time frame: 8 Days
ECG RR-Interval
Safety Analyses
Time frame: 8 Days
ECG QRS-Interval
Safety Analyses
Time frame: 8 Days
ECG QT-Interval
Safety Analyses
Time frame: 8 Days
ECG QTc-Interval
Safety Analyses
Time frame: 8 Days
Vital Sign - Systolic Blood Pressure
Safety Analyses
Time frame: 8 Days
Vital Sign - Diastolic Blood Pressure
Safety Analyses
Time frame: 8 Days
Vital Sign - Pulse Rate
Safety Analyses
Time frame: 8 Days
Vital Sign - Body Temperature
Safety Analyses
Time frame: 8 Days
Vital Sign - Respiratory Rate
Area under the curve (AUC) for plasma AR882
Time frame: 6 Days
Profile from plasma in terms of AUC for AR882
Time to maximum plasma concentration (Tmax) for AR882
Time frame: 6 Days
Profile from plasma in terms of Tmax for AR882
Maximum plasma concentration (Cmax) for AR882
Time frame: 6 Days
Profile from plasma in terms of Cmax for AR882
Apparent terminal half-life (t1/2) for AR882
Time frame: 6 Days
Profile from plasma in terms of t1/2 for AR882
Amount excreted (Ae) into urine for AR882
Time frame: 6 Days
Profile from urine in terms of Ae for AR882
Fractional Excretion (FEUA) for AR882
Time frame: 6 Days
Profile from urine in terms of FEUA for AR882
3 secondary outcomes
PD profile of a single dose of AR882
Time frame: 6 Days
PD profile of a single dose of AR882 in combination with allopurinol
Time frame: 6 Days
PD profile of a single dose of AR882 in combination with febuxostat
Time frame: 6 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1: AR882, Cohort 2: AR882 and Cohort 3: AR882 in people with Healthy Volunteers, run by Arthrosi Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings (time frame: 8 Days). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.