NCT04668274 is a Phase 1 clinical trial of 200 mg resveratrol as JOTROL in Pharmacokinetics, sponsored by Jupiter Orphan Therapeutics Inc..

Who is sponsoring NCT04668274?

NCT04668274 is sponsored by Jupiter Orphan Therapeutics Inc..

What drugs are being tested in NCT04668274?

Interventions in NCT04668274: 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 condition does NCT04668274 study?

NCT04668274 studies Pharmacokinetics, Safety, Food-drug Interaction.

Is NCT04668274 still recruiting?

NCT04668274 is currently completed. Last updated 12 August 2022.

Are results published for NCT04668274?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-12 · How we verify

NCT04668274

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

JOTROL PK, Safety, and Food Effect Assessment

Completed Phase 1 Results posted Last updated 12 August 2022

What this trial tests

Phase 1 trial testing 200 mg resveratrol as JOTROL in Pharmacokinetics in 24 participants. Completed in 31 May 2021.

Timeline

21 January 2021

Primary endpoint
28 February 2021

31 May 2021

Quick facts

Lead sponsor	Jupiter Orphan Therapeutics Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	24
Start date	21 January 2021
Primary completion	28 February 2021
Estimated completion	31 May 2021
Sites	1 location across United States

Drugs / interventions tested

200 mg resveratrol as JOTROL — full drug profile →
500 mg resveratrol as JOTROL — full drug profile →
700 mg resveratrol as JOTROL — full drug profile →
500 mg resveratrol as JOTROL administered to assess influence of food — full drug profile →

Conditions studied

Pharmacokinetics — all drugs for Pharmacokinetics →
Safety — all drugs for Safety →
Food-drug Interaction — all drugs for Food-drug Interaction →

Sponsor

Jupiter Orphan Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Pharmacokinetics or Safety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Primary · From first dose of study drug administration up to 131 days

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 TE

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	7
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	4
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	6
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	6

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) Primary · 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

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.

Resveratrol

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	214.73
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	499.73	± 56.54
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	595.75	± 28.19
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	553.77	± 60.84

Resveratrol-3-Glucuronide

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	4821.18	± 29.37
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	16390.55	± 27.25
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	29570.84	± 34.08
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	11834.05	± 28.41

Resveratrol-3-Sulfate

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	11668.98	± 27.75
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	35063.90	± 31.67
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	53845.25	± 20.62
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	31133.94	± 33.24

Resveratrol-4'-Glucuronide

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	4591.06	± 27.34
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	15387.06	± 29.76
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	22934.42	± 29.90
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	14528.02	± 21.95

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) Primary · 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

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.

Resveratrol

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	112.32	± 72.49
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	422.85	± 53.24
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	785.29	± 51.52
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	263.75	± 65.72

Resveratrol-3-Glucuronide

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	4796.08	± 29.58
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	16347.62	± 27.21
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	29492.22	± 34.04
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	11775.27	± 28.51

Resveratrol-3-Sulfate

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	11593.20	± 26.78
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	34854.48	± 31.49
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	53351.47	± 20.04
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	31018.49	± 33.26

Resveratrol-4'-Glucuronide

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	4550.27	± 27.58
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	15337.45	± 29.70
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	22845.47	± 29.36
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	14502.21	± 21.93

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

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

Resveratrol

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	94.70	± 91.46
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	326.32	± 89.76
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	648.08	± 73.29
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	140.09	± 100.84

Resveratrol-3-Glucuronide

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	2292.84	± 29.69
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	8334.08	± 48.84
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	14558.05	± 46.33
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	4173.48	± 59.28

Resveratrol-3-Sulfate

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	6204.37	± 36.00
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	16863.57	± 48.55
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	22856.79	± 27.23
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	10696.58	± 65.43

Resveratrol-4'-Glucuronide

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	1649.08	± 33.30
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	5340.95	± 56.63
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	7663.09	± 40.20
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	3742.71	± 48.44

Residual Area for Resveratrol Secondary · 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

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.

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	5.48
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	4.56	± 73.50
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	3.58	± 38.56
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	2.29	± 111.16

Time to Maximum Observed Plasma Concentration (Tmax) for Resveratrol Secondary · 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

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

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	0.999	0.250 – 2.006
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	1.003	0.496 – 2.001
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	1.025	0.251 – 2.000
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	1.497	0.499 – 2.002

Elimination Half-Life (T1/2 el) for Resveratrol Secondary · 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

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.

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	1.26
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	2.36	± 62.56
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	1.56	± 25.19
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	1.47	± 71.72

Elimination Rate Constant (Kel) for Resveratrol Secondary · 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

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

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	0.5520
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	0.2932	± 48.70
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	0.4436	± 28.56
Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)	0.4712	± 71.72

Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) for Resveratrol Secondary · Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

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.

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	16927.35	± 75.39
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	48454.76	± 49.88
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	109323.50	± 88.32

Maximum Rate of Urinary Excretion (Rmax) for Resveratrol Secondary · Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

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.

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	8791.49	± 82.45
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	26486.23	± 136.58
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	44737.57	± 90.97

Time of Rmax (Tmax) for Resveratrol Secondary · Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

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

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	0.793	0.233 – 12.013
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	0.551	0.049 – 1.436
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	0.698	0.290 – 3.563

Renal Clearance (CLr) for Resveratrol Secondary · Pre-dose and 4, 8, 12, 24, and 32 hours post-dose on Day 1

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

Group	Value	95% CI
Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)	0.15	± 112.22
Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)	0.11	± 63.04
Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)	0.14	± 95.39

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug administration up to 131 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: JOTROL (Resveratrol) 200 mg (Treatment A)

Serious: 0/21 (0%)

Deaths: 0/21

Part 1: JOTROL (Resveratrol) 500 mg (Treatment B)

Serious: 0/16 (0%)

Deaths: 0/16

Part 1: JOTROL (Resveratrol) 700 mg (Treatment C)

Serious: 0/18 (0%)

Deaths: 0/18

Part 2: JOTROL (Resveratrol) 500 mg (Treatment D)

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (12 terms — click to expand)

Reaction	System	Part 1: JOTROL (Resveratro…	Part 1: JOTROL (Resveratro…	Part 1: JOTROL (Resveratro…	Part 2: JOTROL (Resveratro…
Somnolence	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—
Haemoglobin decreased	Investigations	—	—	—	—
SARS-CoV-2 test positive	Investigations	—	—	—	—
White blood cells urine	Investigations	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04668274 adverse events section.

Sponsor's own description

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. 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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Human Sirtuin Regulators: The "Success" Stories.
Curry AM, White DS, Donu D, Cen Y. · · 2021 · cited 64× · PMID 34744791 · DOI 10.3389/fphys.2021.752117
Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL <sup>TM</sup>).
Kemper C, Benham D, Brothers S, Wahlestedt C, et al · · 2022 · cited 30× · PMID 35789594 · DOI 10.1186/s41120-022-00058-1
Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04668274 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jupiter Orphan Therapeutics Inc.
Last refreshed: 12 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04668274.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04668274

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Pharmacokinetics

Verify against primary sources