HealthyPhase 1NCT02780752
A Study of Oral Hymecromone and Hyaluronan Synthesis
A Phase 1 study testing hymecromone in people with Healthy and Respiratory Disease, run by Paul Bollyky at 1 site in United States.
Trial summary
The purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Respiratory Disease
- What is being tested?
- hymecromone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 10 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18-65 years of age
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam
- BMI between 18.5 - 30 kg/m2
- Taking no medications for at least 1 week before and during study enrollment, including drugs of abuse, prescription or OTC medications
- Male subjects who are heterosexually active must use an acceptable method of contraception (abstinence, condom with or without spermicidal agent, or partner contraceptive use as described in requirements for female subjects) to avoid pregnancy in their partner for the entire study period
- Female subjects who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
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- Be able to provide written informed consent and comply with requirements of the study
- Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
- Be able to read, speak and understand English
- Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
Who cannot join
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia
- Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
- Subjects with liver failure or LFTs above the upper limit of normal
- Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician
- Subjects with a baseline corrected Fridericia's QT interval (QTcF) >450ms and a baseline ECG abnormalities which in the opinion of the study physician, is clinically significant
- Subjects with ongoing alcohol or illegal drug use
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- Subjects who are pregnant, lactating or attempting to conceive
- Known allergy to hymecromone or any component thereof
- Physician concern that participant may not adhere to the study protocol
- Current participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis
The purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate.
This is a parallel, open-label, single-center, dose-response study of hymecromone in healthy adults 18 years of age or older. Up to 18 participants will be enrolled. Participants will be treated for 4 days with study drug. Safety as well as biomarkers of pharmacokinetic and pharmacodynamic response will be monitored during therapy.
- Conditions
- Healthy, Respiratory Disease
- Being tested
- hymecromone
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hymecromoneDrug
Also called 4-Methylumbelliferone
Oral Hymecromone
| Study group | Role | What they receive |
|---|---|---|
| Oral hymecromone 400mg po three times per day | Active comparator | Participants will be administered oral hymecromone 400mg po three times per day (1200 mg) Receives: Drug: hymecromone |
| Oral hymecromone 800 mg po three times per day (2400 mg) | Active comparator | Participants will be be administered oral hymecromone 800 mg po three times per day (2400 mg) Receives: Drug: hymecromone |
| Oral hymecromone 1200 mg three times per day (3600 mg) | Active comparator | Participants will be administered oral hymecromone 1200 mg three times per day (3600 mg) Receives: Drug: hymecromone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sputum hyaluronan concentration over the study period
Measured: From baseline to day 4
Change in serum hyaluronan concentration over the study period
Measured: From baseline to day 4
Change in serum hymecromone concentration over the study period
Measured: From baseline to day 4
Secondary outcomes (1)
The safety and tolerability (as codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0) of oral hymecromone over the study period
Measured: Through study completion, an average of 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start1 Dec 2020
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of three treatment groups, each including up to 6 participants, with treatment over 4 days of different doses of oral hymecromone. Following a wash-out period, participants are allowed to re-enroll into different treatment groups to provide intra-patient dose comparisons.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Bollyky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Bollyky, Stanford University
- Investigators
- Paul Bollyky, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780752
- Sponsor's protocol ID
- IRB-43805
- Status last verified
- Jun 2021
- First submitted
- 17 May 2016
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.
PubMed 37055910Rosser JI, Nagy N, Goel R, Kaber G, Demirdjian S, Saxena J, Bollyky JB, Frymoyer AR, Pacheco-Navarro AE, Burgener EB, Rajadas J, Wang Z, Arbach O, Dunn CE, Kalinowski A, Milla CE, Bollyky PL. Oral hymecromone decreases hyaluronan in human study participants. J Clin Invest. 2022 May 2;132(9):e157983. doi: 10.1172/JCI157983.
PubMed 35499083
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis
- ClinicalTrials.gov ID
- NCT02780752
- Acronym / sponsor ID
- IRB-43805
- Conditions
- Healthy, Respiratory Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Paul BollykyUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 23 May 2016 (estimated)
- 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.
The purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate.
This is a parallel, open-label, single-center, dose-response study of hymecromone in healthy adults 18 years of age or older. Up to 18 participants will be enrolled. Participants will be treated for 4 days with study drug. Safety as well as biomarkers of pharmacokinetic and pharmacodynamic response will be monitored during therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three treatment groups, each including up to 6 participants, with treatment over 4 days of different doses of oral hymecromone. Following a wash-out period, participants are allowed to re-enroll into different treatment groups to provide intra-patient dose comparisons.
| Arm | Type | Receives |
|---|---|---|
| Oral hymecromone 400mg po three times per day | Active comparator | Drug: hymecromoneParticipants will be administered oral hymecromone 400mg po three times per day (1200 mg) |
| Oral hymecromone 800 mg po three times per day (2400 mg) | Active comparator | Drug: hymecromoneParticipants will be be administered oral hymecromone 800 mg po three times per day (2400 mg) |
| Oral hymecromone 1200 mg three times per day (3600 mg) | Active comparator | Drug: hymecromoneParticipants will be administered oral hymecromone 1200 mg three times per day (3600 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female 18-65 years of age
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam
- BMI between 18.5 - 30 kg/m2
- Taking no medications for at least 1 week before and during study enrollment, including drugs of abuse, prescription or OTC medications
- Male subjects who are heterosexually active must use an acceptable method of contraception (abstinence, condom with or without spermicidal agent, or partner contraceptive use as described in requirements for female subjects) to avoid pregnancy in their partner for the entire study period
Key exclusion criteria (10 listed)
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia
- Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
- Subjects with liver failure or LFTs above the upper limit of normal
- Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician
- Subjects with a baseline corrected Fridericia's QT interval (QTcF) >450ms and a baseline ECG abnormalities which in the opinion of the study physician, is clinically significant
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 |
|---|---|---|
| hymecromoneAlso: 4-MethylumbelliferoneOral Hymecromone | Drug | Oral hymecromone 1200 mg three times per day (3600 mg), Oral hymecromone 400mg po three times per day, Oral hymecromone 800 mg po three times per day (2400 mg) |
Primary outcome
Change in sputum hyaluronan concentration over the study period
Time frame: From baseline to day 4
Change in serum hyaluronan concentration over the study period
Time frame: From baseline to day 4
Change in serum hymecromone concentration over the study period
Time frame: From baseline to day 4
1 secondary outcome
The safety and tolerability (as codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0) of oral hymecromone over the study period
Time frame: Through study completion, an average of 11 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 Jun 2021.
- Derived from this study: PubMed 37055910Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.
- Derived from this study: PubMed 35499083Rosser JI, Nagy N, Goel R, Kaber G, Demirdjian S, Saxena J, Bollyky JB, Frymoyer AR, Pacheco-Navarro AE, Burgener EB, Rajadas J, Wang Z, Arbach O, Dunn CE, Kalinowski A, Milla CE, Bollyky PL. Oral hymecromone decreases hyaluronan in human study participants. J Clin Invest. 2022 May 2;132(9):e157983. doi: 10.1172/JCI157983.
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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.
Paul Bollyky, MD principal investigator
Stanford University
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 hymecromone in people with Healthy and Respiratory Disease, run by Paul Bollyky 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 10 inclusion and 10 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 Jun 2021. 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?
Change in sputum hyaluronan concentration over the study period (time frame: From baseline to day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02780752, which also lists 2 linked publications.
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 Jun 2021.