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PharmacokineticsPhase 1NCT04668274

JOTROL PK, Safety, and Food Effect Assessment

A Phase 1 study testing 200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL and 700 mg resveratrol as JOTROL in people with Pharmacokinetics and Safety, run by Jupiter Orphan Therapeutics Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type of Study: Single Ascending Doses (SAD) Study Objectives: To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at 1,000 mg, in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pharmacokinetics, Safety, Food-drug Interaction
What is being tested?
200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL and 700 mg resveratrol as JOTROL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
21 Jan 2021to 31 May 2021
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Normal healthy male or female volunteers, non-smokers (no use of tobacco products within 3 months prior to screening), ≥ 18 and ≤ 75 years of age, with BMI > 18.5 and < 30.0 kg/m 2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
  • Healthy as defined by:
  • the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours predose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator.
  • the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease as determined by the Investigator.
  • Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
  • intra-uterine contraceptive device without hormone release system placed at least 4 weeks prior to study drug administration;
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  • male condom with intravaginally applied spermicide starting at least 21 days prior to study drug administration;
  • sterile male partner (vasectomized since at least 6 months).
  • Capable of consent

Who cannot join

  • Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
  • Positive urine drug screen or urine cotinine test at screening.
  • History of allergic reactions to resveratrol, polyphenols, other related drugs, .
  • or to any excipient in the formulation
  • Positive pregnancy test at screening.
  • Breast-feeding subject.
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  • Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
  • History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
  • History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
  • Use of resveratrol for a medical condition or in the context of another clinical trial within a period of 30 days prior to the first dosing.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
  • Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
  • prescription medication within 14 days prior to the first dosing;
  • over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
  • use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration, including St John's wort;
  • depot injection or an implant of any drug within 3 months prior to the first dosing.
  • 12. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
  • 13. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • inVentiv Health Clinical Research Services LLC, a Syneos Health company (" Syneos Health ")

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 1 Study to Assess the Pharmacokinetics and Safety of Ascending Doses of JOTROL Oral Gelcaps in Healthy Subjects, and to Determine the Influence of Food

Type of Study: Single Ascending Doses (SAD) Study

Objectives:

Read more

To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at 1,000 mg, in healthy subjects.

To evaluate the safety and tolerability of JOTROL To evaluate the effect of food on the PK profile of JOTROL. Study Design: Phase I, randomized, open-label, sequential SAD study with a food effect evaluation. Blood plasma and urine samples will be assessed for resveratrol and key metabolite content.

Type of Control: No control Test Product: JOTROL (resveratrol) 100 mg resveratrol in 1000 mg softgel capsule for oral administration Dosage Regimen: Planned dose levels of resveratrol: 200 mg, 500 mg, and 1,000 mg. Following completion of each dose level, PK, safety, and tolerability data will be evaluated; dose levels may be adjusted.

Route of Administration: Oral gelcaps with water Number of Subjects: 24 subjects will be included in Part 1; only 16 subjects, who completed Part 1, will be included in Part 2.

Subjects: Healthy, non-smoker, adult males or females, ≥ 18 and ≤ 75 years of age Study Duration: Participation of each subject in this study should last approximately 1 to 1.5 months (for subjects participating in study Part 1 only) and 1.5 to 2 months (for subjects participating in both study parts).

Being tested
200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL, 700 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL administered to assess influence of food

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 200 mg resveratrol as JOTROLDrug

    Low (first) dose of single ascending dose study

  • 500 mg resveratrol as JOTROLDrug

    Second (intermediate) dose of single ascending dose study

  • 700 mg resveratrol as JOTROLDrug

    Third (highest) dose of single ascending dose study

  • 500 mg resveratrol as JOTROL administered to assess influence of foodDrug

    500 mg resveratrol as JOTROL administered to assess influence of food

Study groups in NCT04668274
Study groupRoleWhat they receive
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)ExperimentalParticipants received JOTROL (resveratrol) 200 (2*100) milligram (mg) (Treatment A), gelatin capsule (gelcap), orally, once on Day 1 in fasted conditions in Study Period 1.
Receives: Drug: 200 mg resveratrol as JOTROL
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)ExperimentalParticipants who completed Study Period 1 received JOTROL (resveratrol) 500 (5*100) mg (Treatment B), gelcap, orally, once on Day 1 in fasted conditions in Study Period 2. A 14 days washout period was maintained in study period 1 and 2.
Receives: Drug: 500 mg resveratrol as JOTROL
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)ExperimentalParticipants who completed Study Period 2 received JOTROL (resveratrol) 700 (7*100) mg (Treatment C), gelcap, orally, once on Day 1 in fasted conditions in Study Period 3. A 14 days washout period was maintained in study period 2 and 3.
Receives: Drug: 700 mg resveratrol as JOTROL
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)ExperimentalParticipants who completed Study Period 3 (Part 1) received JOTROL (resveratrol) 500 (5*100) mg (Treatment D), gelcap, orally, once on Day 1 in fed conditions in Study Period 4. A 14 days washout period was maintained in study period 3 and 4.
Receives: Drug: 500 mg resveratrol as JOTROL administered to assess influence of food

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence (including clinically significant [CS] vital signs measurements or laboratory results) or worsening of a pre-existing condition in a participant administered a pharmaceutical product during the course of the study, whether related or not to the study medication. TEAEs were defined as AE that occurred on or after the date and time of study drug administration or those that first occurred pre-dose but worsened by increase in occurrence or severity after study drug administration. TEAEs includes both serious and non-serious TEAEs.

    Measured: From first dose of study drug administration up to 131 days

  2. Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity (AUC0-inf) for Resveratrol and Its Metabolites (Resveratrol-3-glucuronide, Resveratrol-4'-Glucuronide, and Resveratrol-3-sulfate)

    AUC(0-infinity) of resveratrol, resveratrol-3-glucuronide, resveratrol-4'-glucuronide, and resveratrol-3-sulfate in plasma were reported. AUC(0-infinity) of resveratrol, resveratrol-3-glucuronide, resveratrol-4'-glucuronide, and resveratrol-3-sulfate in plasma were reported and calculated as AUC0-t + Ct/Kel, where Ct is the last observed measurable concentration, AUC0-t is Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration and Kel is Elimination rate constant.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

  3. Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) for Resveratrol and Its Metabolites (Resveratrol-3-glucuronide, Resveratrol-4'-Glucuronide, and Resveratrol-3-sulfate)

    AUC0-t was Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

  4. Maximum Observed Plasma Concentration (Cmax) for Resveratrol and Its Metabolites (Resveratrol-3-glucuronide, Resveratrol-4'-Glucuronide, and Resveratrol-3-sulfate)

    Cmax was the maximum observed plasma concentration obtained directly from the concentration versus time curve.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

Secondary outcomes (8)

  1. Residual Area for Resveratrol

    Residual area for resveratrol in plasma was calculated and reported. The residual area was calculated as 100*(1- AUC0-t / AUC0-inf) where AUC0-t (h*ng/mL) = area under the concentration-time curve from time zero to the last measurable concentration and AUC0-inf (h*ng/mL) = area under the plasma concentration-time curve from time 0 to time of infinity.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

  2. Time to Maximum Observed Plasma Concentration (Tmax) for Resveratrol

    Tmax was time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

  3. Elimination Half-Life (T1/2 el) for Resveratrol

    Elimination half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

  4. Elimination Rate Constant (Kel) for Resveratrol

    Kel was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

    Measured: Pre-dose and 0.133, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1

  5. Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) for Resveratrol

    Cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval. The amount excreted in urine for each time interval was calculated as the urine concentration multiplied by the urine volume.

    Measured: Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

  6. Maximum Rate of Urinary Excretion (Rmax) for Resveratrol

    Maximum rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected.

    Measured: Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

  7. Time of Rmax (Tmax) for Resveratrol

    Tmax was the time after administration of a drug when the Rmax is reached.

    Measured: Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

  8. Renal Clearance (CLr) for Resveratrol

    CLr was calculated as Ae0-t/AUC0-t (plasma) where t is Tlast.

    Measured: Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start21 Jan 2021
  3. Primary completion28 Feb 2021
  4. Study completion31 May 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04668274
Sponsor's protocol ID
Protocol 202016
Other IDs
R44AG067907-01A1
Status last verified
Jun 2022
First submitted
2 Dec 2020
Last updated
12 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kemper C, Benham D, Brothers S, Wahlestedt C, Volmar CH, Bennett D, Hayward M. Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM). AAPS Open. 2022;8(1):11. doi: 10.1186/s41120-022-00058-1. Epub 2022 Jun 30.

    PubMed 35789594

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL and 700 mg resveratrol as JOTROL in people with Pharmacokinetics and Safety, run by Jupiter Orphan Therapeutics 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 12 Aug 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 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?

Yes. Results are posted in the registry (first posted 12 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of study drug administration up to 131 days). The study lists 4 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 NCT04668274, which also lists 1 linked publication.

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 12 Aug 2022.

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