Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM) | NCT02114957

Studies
Pharmacokinetics of Decursin/Decursinol Angelate (CognIQTM)

NCT02114957

Sponsor

Texas Tech University Health Sciences Center

Status

Completed

Last Update Posted

Apr 15, 2014Estimated

Enrollment

20Actual

Phase

Early Phase 1

Conditions

Healthy

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Actual

Completion Date

Not provided

First Submitted Date

Apr 11, 2014

First Submission Date that Met QC Criteria

Apr 14, 2014

First Posted Date

Apr 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2014

Last Update Posted Date

Apr 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study herb	Experimental		Dietary Supplement: 800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0

Interventions

Name	Type	Description	Arm Group Labels	Other Names
800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0	Dietary Supplement		study herb

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinhui Zhang, Ph.D	Texas Tech University Health Sciences Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Unit, School of Medicine, Texas Tech University Health Sciences Center		Amarillo	Texas	79106	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25695490	Derived	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.