Overview

This trial is active, not recruiting.

Condition the pharmacokinetic profile of icariin in humans
Treatments icariin, matching placebo
Phase phase 1
Sponsor University of Texas Southwestern Medical Center
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date April 2014
End date September 2016
Trial size 24 participants
Trial identifier NCT02112123, 102012-052, 1R21AT007869-01

Summary

The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Placebo Comparator)
Matching placebo given for 5 days (qd po)
matching placebo
(Active Comparator)
Icariin given at 100 mg/day (qd po) for 5 days
icariin Horny Goat Weed
(Active Comparator)
Icariin given at 200 mg/day (qd po) for 5 days
icariin Horny Goat Weed
(Active Comparator)
Icariin given at 400 mg/day (qd po) for 5 days
icariin Horny Goat Weed
(Active Comparator)
Icariin given at 840 mg/day (qd po) for 5 days
icariin Horny Goat Weed
(Active Comparator)
Icariin given at 1680 mg/day (qd po) for 5 days
icariin Horny Goat Weed

Primary Outcomes

Measure
Blood concentration levels of icariin
time frame: 24 hours

Secondary Outcomes

Measure
A-SEX
time frame: 5 days
SAFTEE
time frame: 5 days
PT/PTT levels
time frame: 5 days

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - Healthy men and women - Ages 18 - 50 years - BMI between 18.5 and 30 - Ability to read and speak English - Education of 12 or more years or equivalent (at least GED received) Exclusion Criteria: - Medication changes in the past 30 days - History of psychotropic medication therapy in the past 30 days - Current or past 30 days opioid therapy - Current or past 30 days erectile dysfunction therapy - Significant medical conditions - Hypertensive blood pressure, defined as either systolic pressure > 140 or diastolic pressure > 90 - Baseline heart rate > 100 bpm or < 50 bpm - History of major psychiatric illness - History of drug/alcohol abuse or current tobacco use - Vulnerable populations including pregnant or nursing women, the incarcerated, or individuals with severe cognitive disorders - History of allergic reaction or contraindication to icariin - Baseline QIDS score > 7, current suicidal ideation, or history of suicide attempt - Education history that includes Special Education or history of mental disability - Clinically significant abnormalities on baseline labs and ECG results - Current participation in any other pharmacotherapy studies

Additional Information

Official title Icariin to Prevent Corticosteroid-related Memory Changes
Principal investigator E. Sherwood Brown, M.D., Ph.D.
Description The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed. Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo. 24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.