Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0

• Registration Number: NCT02114957
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

This study is to investigate how human bodies absorb and metabolize two herbal drugs. The information is critical for drug development and could not be obtained from any other studies using animals. The two herbal drugs are decursin and decursinol angelate (DA) which naturally exist in a traditional herb Angelica gigas Nakai (AGN). Preclinical and clinical studies indicated that AGN and decursin/DA were quite safe to animals and human.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-04
• Status Verified: 2014-04
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Health subjects weighing between 50 to 91 kilograms (110 to 200 pounds)
• Subjects 18 to 65 years of age
• Subjects having normal hepatic, renal and bone marrow function as assessed by history, physical and clinical chemistry analysis

Exclusion Criteria

• Subjects positive for HIV, HBV and HCV
• Subjects with diabetes-due to length of fasting
• Subjects regularly taking any kind of prescription medications
• Subjects taking oral contraception, hormone-containing IUDs, contraception implants, or Depo medroxyprogesterone injections
• Subjects taking any food or herbal supplements containing AGN (e.g. CognIQTM, D-Cursinol, Decursinol-50™, Ache Action™, Fast-Acting Joint Formula, EstroG-100™) within 30 days of the study.
• Female subjects that are pregnant, <6 months postpartum, or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study herb	800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of decursin, decursinol angelate (DA) and decursinol	0, 0.5, 1, 2, 3, 4, 6, 8, 12 , 24, 48 hours post-dose

Secondary Outcome Measures

Name	Time	Method
vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb	0 and 24 hours post-dose

Trial Locations

Locations (1)

Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center; 🇺🇸 Amarillo, Texas, United States