NCT04668274

JOTROL PK, Safety, and Food Effect Assessment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jupiter Orphan Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-02-28
• Completion: 2021-05-31
• First posted: 2020-12-16
• Last updated: 2022-08-12
• Results posted: 2022-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study