HealthyPhase 1NCT06325930
A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6
A Phase 1 study testing [14C]-HU6 in people with Healthy, run by Rivus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of [14C]-HU6 in a fed state with a standard meal administered approximately 15 minutes… 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
- What is being tested?
- [14C]-HU6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 7 May 2024
- 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
- Capable of understanding the written informed consent form (ICF), willingly provide valid, signed written informed consent and willing and able to comply with the schedule, requirements and restrictions of the study
- Healthy males between 18.0 and 55.0 years of age (inclusive) at the time of Screening.
- Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.5 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
- Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital signs (VS) measurements, 12-lead electrocardiogram (ECG), and clinical laboratory test results.
- Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
- is documented to be surgically sterile (i.e., successfully vasectomized), or
- agrees to use 2 methods of highly effective contraception (e.g, condom plus spermicide) and female partner's use of a reliable form of contraception during intercourse for the duration of the study, and for at least 90 days after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 90 days post dose.
Who cannot join
- History or presence of any condition (e.g., chronic diarrhea), gastrointestinal bleeding, including related to hemorrhoids or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives.
- History of cancer that has not been in complete remission for > 5 years (except basal cell skin cancer or squamous cell skin cancer with a history of curative treatment and no recurrence for > 1 year prior to Screening), as judged by the Investigator.
- Acute illness within 14 days prior to study drug administration on Day 1, unless mild in severity and enrollment is approved by both the Investigator and Sponsor's medical representative.
- History of COVID symptoms or positive COVID test within 2 weeks prior to admission date.
- Any history of serious allergic drug reactions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center (CPC)
Baltimore, Maryland, 21201
About this study
Official title: An Open-Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6 Following Single-Dose Oral Administration
This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of [14C]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.
Read the detailed description
This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of [14C]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.
Healthy, adult males aged 18 to 55, inclusive, who have provided written informed consent, will be screened, and subjects who meet all eligibility criteria may be enrolled into the study within 28 days of Screening.
Approximately 8 eligible subjects will be admitted on Day -1, and baseline assessments will be completed. On Day 1, 8 subjects will receive a single dose of [14C]-HU6 in a fed state. If ≥ 85% (mean of all subjects) of the 14C label has been recovered in samples collected and analyzed through 336 hours after dosing and the mean of individual 14C recovery is < 1% on each of 2 consecutive days, all subjects will be discharged from the Pharmaron Clinical Pharmacology Center (CPC) on Day 15 after completion of all 336-hour timepoint assessments.
- Conditions
- Healthy
- Being tested
- [14C]-HU6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-HU6Drug
[14C]-HU6 following a single dose of HU6 in healthy, adult male subjects
| Study group | Role | What they receive |
|---|---|---|
| single dose of [14C]-HU6 | Experimental | Not described Receives: Drug: [14C]-HU6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the mass balance
(i.e., the cumulative excretion of total 14C in urine and feces), of [14C]-HU6 following a single dose of [14C]-HU6, in healthy, adult male subjects
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start26 Mar 2024
- Primary completion7 May 2024
- Study completion7 May 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rivus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325930
- Sponsor's protocol ID
- RIV-HU6-105
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 21 May 2024
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6 Following Single-Dose Oral Administration
- ClinicalTrials.gov ID
- NCT06325930
- Acronym / sponsor ID
- RIV-HU6-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rivus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 22 Mar 2024 (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 a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of [14C]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.
Detailed description
This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of [14C]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.
Healthy, adult males aged 18 to 55, inclusive, who have provided written informed consent, will be screened, and subjects who meet all eligibility criteria may be enrolled into the study within 28 days of Screening.
Approximately 8 eligible subjects will be admitted on Day -1, and baseline assessments will be completed. On Day 1, 8 subjects will receive a single dose of [14C]-HU6 in a fed state. If ≥ 85% (mean of all subjects) of the 14C label has been recovered in samples collected and analyzed through 336 hours after dosing and the mean of individual 14C recovery is < 1% on each of 2 consecutive days, all subjects will be discharged from the Pharmaron Clinical Pharmacology Center (CPC) on Day 15 after completion of all 336-hour timepoint assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single dose of [14C]-HU6 | Experimental | Drug: [14C]-HU6 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of understanding the written informed consent form (ICF), willingly provide valid, signed written informed consent and willing and able to comply with the schedule, requirements and restrictions of the study
- Healthy males between 18.0 and 55.0 years of age (inclusive) at the time of Screening.
- Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.5 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
- Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital signs (VS) measurements, 12-lead electrocardiogram (ECG), and clinical laboratory test results.
- Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
Key exclusion criteria (5 listed)
- History or presence of any condition (e.g., chronic diarrhea), gastrointestinal bleeding, including related to hemorrhoids or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives.
- History of cancer that has not been in complete remission for > 5 years (except basal cell skin cancer or squamous cell skin cancer with a history of curative treatment and no recurrence for > 1 year prior to Screening), as judged by the Investigator.
- Acute illness within 14 days prior to study drug administration on Day 1, unless mild in severity and enrollment is approved by both the Investigator and Sponsor's medical representative.
- History of COVID symptoms or positive COVID test within 2 weeks prior to admission date.
- Any history of serious allergic drug reactions.
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]-HU6[14C]-HU6 following a single dose of HU6 in healthy, adult male subjects | Drug | single dose of [14C]-HU6 |
Primary outcome
To assess the mass balance
Time frame: Up to Day 29
(i.e., the cumulative excretion of total 14C in urine and feces), of [14C]-HU6 following a single dose of [14C]-HU6, in healthy, adult male subjects
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 21 May 2024.
- 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]-HU6 in people with Healthy, run by Rivus Pharmaceuticals, Inc. 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 7 inclusion and 5 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 21 May 2024. 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?
To assess the mass balance (time frame: Up to Day 29). 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 21 May 2024.