Healthy VolunteersPhase 1NCT04508426
Single-dose AME Study With [14C]AR882 in Healthy Male Subjects
A Phase 1 study testing [14C]AR882 in people with Healthy Volunteers, run by Arthrosi Therapeutics at 1 site in United States.
Trial summary
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and… 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?
- [14C]AR882
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 12 Aug 2020
- 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
- Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
- Must have a minimum of 1 bowel movement every 2 days
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
Who cannot join
- Inadequate venous access or unsuitable veins for repeated venipuncture
- Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]AR882
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]AR882Drug
Single dose of [14C]AR882
| Study group | Role | What they receive |
|---|---|---|
| Mass Balance | Experimental | Not described Receives: Drug: [14C]AR882 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity (TRA) in urine
Measured: Days 1-14
TRA in feces
Measured: Days 1-14
TRA concentration equivalents in plasma
Measured: Days 1-14
TRA concentration equivalents in whole blood
Measured: Days 1-14
Area under the curve (AUC) for plasma [14C]-AR882
Profile from plasma in terms of AUC following a single dose of [14C]-AR882
Measured: 7 Days
Time to maximum plasma concentration (Tmax) for [14C]-AR882
Profile from plasma in terms of Tmax following a single dose of [14C]-AR882
Measured: 7 Days
Maximum plasma concentration (Cmax) for [14C]-AR882
Profile from plasma in terms of Cmax following a single dose of [14C]-AR882
Measured: 7 Days
Apparent terminal half-life (t1/2) for [14C]-AR882
Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882
Measured: 7 Days
Secondary outcomes (1)
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882
Measured: Days 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start16 Jul 2020
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508426
- Sponsor's protocol ID
- AR882-103
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 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, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT04508426
- Acronym / sponsor ID
- AR882-103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 11 Aug 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.
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mass Balance | Experimental | Drug: [14C]AR882 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
- Must have a minimum of 1 bowel movement every 2 days
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
Key exclusion criteria (2 listed)
- Inadequate venous access or unsuitable veins for repeated venipuncture
- Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B
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 |
|---|---|---|
| [14C]AR882Single dose of [14C]AR882 | Drug | Mass Balance |
Primary outcome
Total radioactivity (TRA) in urine
Time frame: Days 1-14
TRA in feces
Time frame: Days 1-14
TRA concentration equivalents in plasma
Time frame: Days 1-14
TRA concentration equivalents in whole blood
Time frame: Days 1-14
Area under the curve (AUC) for plasma [14C]-AR882
Time frame: 7 Days
Profile from plasma in terms of AUC following a single dose of [14C]-AR882
Time to maximum plasma concentration (Tmax) for [14C]-AR882
Time frame: 7 Days
Profile from plasma in terms of Tmax following a single dose of [14C]-AR882
Maximum plasma concentration (Cmax) for [14C]-AR882
Time frame: 7 Days
Profile from plasma in terms of Cmax following a single dose of [14C]-AR882
Apparent terminal half-life (t1/2) for [14C]-AR882
Time frame: 7 Days
Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882
1 secondary outcome
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882
Time frame: Days 1-14
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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Screening Protocol
Pain
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 [14C]AR882 in people with Healthy Volunteers, run by Arthrosi Therapeutics at 1 site in United States.
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 2 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 United States. 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. 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?
Total radioactivity (TRA) in urine (time frame: Days 1-14). The study lists 8 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.