HealthyPhase 1NCT05023811
A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects
A Phase 1 study testing [14C]RIST4271 in people with Healthy and ADME, run by Aristea Therapeutics, Inc. at 1 site in United Kingdom.
Trial summary
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- What is being tested?
- [14C]RIST4271
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2021to 15 Sep 2021
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Must provide written informed consent
- Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening
- Weight ≥50 kg and ≤100 kg inclusive at screening
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
Who cannot join
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Evidence of current SARS-CoV-2 infection
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
- Being tested
- [14C]RIST4271
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]RIST4271Drug
[14C]RIST4271 oral solution
| Study group | Role | What they receive |
|---|---|---|
| [14C]RIST4721 | Experimental | [14C]RIST4721 oral solution Receives: Drug: [14C]RIST4271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity in all excreta: CumAe
Measured: Day 1 to Day 17
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Measured: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Ae
Measured: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by %Ae
Measured: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by CumAe
Measured: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval
Measured: Day 1 to Day 17
Collection of plasma, urine and fecal samples for metabolite profiling
Measured: Day 1 to Day 17
Collection of plasma, urine and fecal samples for structural identification
Measured: Day 1 to Day 17
Collection of plasma, urine and fecal samples for quantification analysis
Measured: Day 1 to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start11 Aug 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristea Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023811
- Sponsor's protocol ID
- RIST4721-104
- Status last verified
- Jan 2022
- First submitted
- 11 Aug 2021
- Last updated
- 10 Jan 2022
- Results posted
- 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 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05023811
- Acronym / sponsor ID
- RIST4721-104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aristea Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 27 Aug 2021 (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 Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]RIST4721 | Experimental | Drug: [14C]RIST4271[14C]RIST4721 oral solution |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males
- Must provide written informed consent
- Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening
- Weight ≥50 kg and ≤100 kg inclusive at screening
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
Key exclusion criteria (3 listed)
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Evidence of current SARS-CoV-2 infection
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
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]RIST4271[14C]RIST4271 oral solution | Drug | [14C]RIST4721 |
Primary outcome
Mass balance recovery of total radioactivity in all excreta: CumAe
Time frame: Day 1 to Day 17
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Ae
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by %Ae
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by CumAe
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval
Time frame: Day 1 to Day 17
Collection of plasma, urine and fecal samples for metabolite profiling
Time frame: Day 1 to Day 17
Collection of plasma, urine and fecal samples for structural identification
Time frame: Day 1 to Day 17
Collection of plasma, urine and fecal samples for quantification analysis
Time frame: Day 1 to Day 17
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 10 Jan 2022.
- 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 [14C]RIST4271 in people with Healthy and ADME, run by Aristea Therapeutics, Inc. at 1 site in United Kingdom.
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 5 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 10 Jan 2022. 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 Kingdom. 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?
Mass balance recovery of total radioactivity in all excreta: CumAe (time frame: Day 1 to Day 17). The study lists 9 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 10 Jan 2022.