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JOTROL PK, Safety, and Food Effect Assessment

NCT04668274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-08-12

Study results available
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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.

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).

Conditions

  • Pharmacokinetics
  • Safety
  • Food-drug Interaction

Interventions

DRUG

200 mg resveratrol as JOTROL

Low (first) dose of single ascending dose study

DRUG

500 mg resveratrol as JOTROL

Second (intermediate) dose of single ascending dose study

DRUG

700 mg resveratrol as JOTROL

Third (highest) dose of single ascending dose study

DRUG

500 mg resveratrol as JOTROL administered to assess influence of food

500 mg resveratrol as JOTROL administered to assess influence of food

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Jupiter Orphan Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2021-02-28
Completion
2021-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668274 on ClinicalTrials.gov