Icariin to Prevent Corticosteroid-related Memory Changes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Icariin to Prevent Corticosteroid-related Memory Changes

Conditions
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the Pharmacokinetic Profile of Icariin in Humans

Intervention / Treatment
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* Drug: Icariin
* Dietary Supplement: Matching placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching placebo given for 5 days (qd po) | Dietary Supplement: Matching placebo<br> <br> |
| Active Comparator: Icariin - 100 mg/day<br>Icariin given at 100 mg/day (qd po) for 5 days | Drug: Icariin<br> <br> * Other names: epimedium extract;|
| Active Comparator: Icariin - 200 mg/day<br>Icariin given at 200 mg/day (qd po) for 5 days | Drug: Icariin<br> <br> * Other names: epimedium extract;|
| Active Comparator: Icariin - 400 mg/day<br>Icariin given at 400 mg/day (qd po) for 5 days | Drug: Icariin<br> <br> * Other names: epimedium extract;|
| Active Comparator: Icariin - 840 mg/day<br>Icariin given at 840 mg/day (qd po) for 5 days | Drug: Icariin<br> <br> * Other names: epimedium extract;|
| Active Comparator: Icariin - 1680 mg/day<br>Icariin given at 1680 mg/day (qd po) for 5 days | Drug: Icariin<br> <br> * Other names: epimedium extract;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration levels of icariin |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A-SEX | Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning. | 5 days | 
| SAFTEE | Systematic Assessment for Treatment Emergent Events - to assess general side effects | 5 days | 
| PT/PTT levels | Prothrombin time/Partial thromboplastin time | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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icariin, pharmacokinetics, healthy participants