Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

NCT02114957 | Completed Early Phase 1

• 1 other identifier: A12-3742
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

bio-availability; decursin; decursinol angelate; decursinol; subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• vital signs, plasma biochemistry and blood cell counts of subjects after consumption the study herb

  0 and 24 hours post-dose

Study Arms (1)

study herb

EXPERIMENTAL

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

Interventions

800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0 DIETARY_SUPPLEMENT

study herb

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center

Amarillo, Texas, 79106, United States

Location

Related Publications (1)

• Zhang J, Li L, Hale TW, Chee W, Xing C, Jiang C, Lu J. Single oral dose pharmacokinetics of decursin and decursinol angelate in healthy adult men and women. PLoS One. 2015 Feb 19;10(2):e0114992. doi: 10.1371/journal.pone.0114992. eCollection 2015.

  PMID: 25695490 DERIVED

Study Officials

• Jinhui Zhang, Ph.D

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 15, 2014
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

US (1)