HealthyPhase 1NCT06486558
Relative Bioavailability Study of HU6
A Phase 1 study testing HU6 450 mg Tablet and HU6 150 mg Capsules x 3 (Total dose = 450 mg) in people with Healthy, run by Rivus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HU6 450 mg Tablet and HU6 150 mg Capsules x 3 (Total dose = 450 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2024to 15 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age, inclusive, at time of informed consent.
- Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative serum pregnancy test at Screening and admission to CRU, and using, and agree to continue using, an effective method of contraception for at least 4 weeks or barrier method for 2 weeks prior to first study drug administration until 30 days after the last dose of study drug.
- Female subjects of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, oophorectomy) or post-menopausal (no menses for >1 year with follicle stimulating hormone (FSH) >40 U/L at Screening).
- Female subjects of childbearing potential must not donate ova during the study and for at least 30 days after the last dose of study drug.
- Male subjects who have not had a vasectomy and/or subjects who have had a vasectomy but have not had 2 post-surgery negative tests for sperm must agree to use an acceptable method of contraception from time of first dose of study drug until 30 days after the last dose of the study drug, and to not donate sperm during the study and for at least 30 days after the last dose of study drug.
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 30.0 kg/m2 at Screening.
Show all 9Show fewer
- Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
- Willing and able to comply with the requirements of the study protocol.
Who cannot join
- Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the investigator in consultation with the medical monitor, which may impact safety.
- History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- Any surgical or medical condition or history that, in the opinion of the investigator in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of study drug, such as, but not limited to, gastric bypass surgery or significant small bowel resections.
- Contraindication to study drug or its excipients and/or history of or anaphylactic reactions or clinically significant allergic reaction.
- Resting heart rate <45 or >100 bpm, systolic blood pressure <90 or >160 mm Hg, or diastolic blood pressure <50 or >110 mmHg.
- On screening ECG and by history:
Show all 18Show fewer
- A marked baseline prolongation of QT/QTcF interval (e.g., repeated demonstration of a QTcF interval >450 msec for males and >470 msec for females).
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or a family history (immediate family member or grandparent < 60 years of age) of sudden cardiac death of unknown origin.
- Use of any prescription medication or over-the counter medications (including multivitamins, herbal-containing preparations, and products with cannabidiol [CBD]) within 14 days prior to admission to the CRU.
- Exceptions:
- Hormonal contraceptives and hormone replacement therapies (oral, injectable, transdermal, or implanted) are permitted.
- Topical medication for skin disorders may be added at the discretion of the Investigator in consultation with the Medical Monitor, if it is determined there is no significant systemic absorption of the medication which may impact other exclusions of medications noted above.
- Acetaminophen use up to 1000 mg per day is permitted.
- Ibuprofen (or other nonsteroidal anti-inflammatory drug [NSAID]) is prohibited within 1 day prior to admission to the CRU.
- Consumption of any food or drink/beverage containing grapefruit or grapefruit juice, pomelo juice, star fruit, Seville or Moro (blood) orange products within 7 days before admission to CRU. Vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) must not be consumed within 24 hours before admission to CRU.
- History of significant drug abuse (i.e., cocaine, phencyclidine, opioid derivatives including heroin, and amphetamine derivatives) within one year prior to Screening. Marijuana use (and other tetrahydrocannabinol [THC] containing products) is prohibited within 7 days prior to Screening and throughout the study.
- History of regular alcohol consumption exceeding 7 drinks/week [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months of Screening.
- Positive urine drug screen for drugs of abuse or positive urine alcohol screen (or breathalyzer alcohol test) at Screening or Admission. Note that positive THC is acceptable at Screening based on Investigator judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Two-Part Study to Assess the Safety and Pharmacokinetics of Tablet and Capsule Formulations of HU6 in Healthy Subjects.
This is a 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.
Read the detailed description
This is a 2-part study. Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Forty subjects will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) or capsule (reference) formulation in the fasted state. Fourteen days will separate dosing in Period 1 and Period 2. After Part 1 is completed, the Part 1 pharmacokinetic blood samples will be shipped for bioanalysis. Study conduct will proceed to Part 2. Fourteen days will separate dosing in Part 1 Period 2 and Part 2 Period 1.
Part 2 is an open-label, randomized, Latin-square 2x2 crossover study. The approximately 40 subjects who participated in Part 1 will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) formulation in the high fat fed state or the low fat fed state. Fourteen days will separate dosing in Period 1 and Period 2
- Conditions
- Healthy
- Being tested
- HU6 450 mg Tablet, HU6 150 mg Capsules x 3 (Total dose = 450 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU6 450 mg TabletDrug
new 450 mg tablet test formulation
HU6 150 mg Capsules x 3 (Total dose = 450 mg)Drug
150 mg capsule reference formulation (3 x 150 mg).
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment HU6 450 mg tablet | Experimental | Not described Receives: Drug: HU6 450 mg Tablet |
| Active Treatment HU6 450 mg Capsules (150 mg x 3) | Experimental | Not described Receives: Drug: HU6 150 mg Capsules x 3 (Total dose = 450 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable time point (AUC0-t),
Measured: 14 days
Maximum concentration (Cmax)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start24 Jul 2024
- Primary completion15 Nov 2024
- Study completion15 Dec 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT06486558
- Sponsor's protocol ID
- RIV-HU6-106
- Status last verified
- Apr 2025
- First submitted
- 18 Jun 2024
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Two-Part Study to Assess the Safety and Pharmacokinetics of Tablet and Capsule Formulations of HU6 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06486558
- Acronym / sponsor ID
- RIV-HU6-106
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Rivus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 3 Jul 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 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.
Detailed description
This is a 2-part study. Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Forty subjects will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) or capsule (reference) formulation in the fasted state. Fourteen days will separate dosing in Period 1 and Period 2. After Part 1 is completed, the Part 1 pharmacokinetic blood samples will be shipped for bioanalysis. Study conduct will proceed to Part 2. Fourteen days will separate dosing in Part 1 Period 2 and Part 2 Period 1.
Part 2 is an open-label, randomized, Latin-square 2x2 crossover study. The approximately 40 subjects who participated in Part 1 will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) formulation in the high fat fed state or the low fat fed state. Fourteen days will separate dosing in Period 1 and Period 2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment HU6 450 mg tablet | Experimental | Drug: HU6 450 mg Tablet |
| Active Treatment HU6 450 mg Capsules (150 mg x 3) | Experimental | Drug: HU6 150 mg Capsules x 3 (Total dose = 450 mg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female between 18 and 55 years of age, inclusive, at time of informed consent.
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 30.0 kg/m2 at Screening.
- Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
- Willing and able to comply with the requirements of the study protocol.
Key exclusion criteria (18 listed)
- Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the investigator in consultation with the medical monitor, which may impact safety.
- History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- Any surgical or medical condition or history that, in the opinion of the investigator in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of study drug, such as, but not limited to, gastric bypass surgery or significant small bowel resections.
- Contraindication to study drug or its excipients and/or history of or anaphylactic reactions or clinically significant allergic reaction.
- Resting heart rate <45 or >100 bpm, systolic blood pressure <90 or >160 mm Hg, or diastolic blood pressure <50 or >110 mmHg.
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 |
|---|---|---|
| HU6 450 mg Tabletnew 450 mg tablet test formulation | Drug | Active Treatment HU6 450 mg tablet |
| HU6 150 mg Capsules x 3 (Total dose = 450 mg)150 mg capsule reference formulation (3 x 150 mg). | Drug | Active Treatment HU6 450 mg Capsules (150 mg x 3) |
Primary outcome
Area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable time point (AUC0-t),
Time frame: 14 days
Maximum concentration (Cmax)
Time frame: 14 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 18 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Active, not recruiting
Deliver-EE: Evaluating Effects of Meal Delivery
Healthy
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
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 HU6 450 mg Tablet and HU6 150 mg Capsules x 3 (Total dose = 450 mg) 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 9 inclusion and 18 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 18 Apr 2025. 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?
Area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable time point (AUC0-t), (time frame: 14 days). The study lists 2 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 18 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.