Icariin to Prevent Corticosteroid-related Memory Changes

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: the Pharmacokinetic Profile of Icariin in Humans

Treatments: Dietary Supplement: Matching placebo; Drug: Icariin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02112123

102012-052

1R21AT007869-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo given for 5 days (qd po)

Treatment:

Dietary Supplement: Matching placebo

Icariin - 100 mg/day

Active Comparator group

Description:

Icariin given at 100 mg/day (qd po) for 5 days

Treatment:

Drug: Icariin

Icariin - 200 mg/day

Active Comparator group

Description:

Icariin given at 200 mg/day (qd po) for 5 days

Treatment:

Drug: Icariin

Icariin - 400 mg/day

Active Comparator group

Description:

Icariin given at 400 mg/day (qd po) for 5 days

Treatment:

Drug: Icariin

Icariin - 840 mg/day

Active Comparator group

Description:

Icariin given at 840 mg/day (qd po) for 5 days

Treatment:

Drug: Icariin

Icariin - 1680 mg/day

Active Comparator group

Description:

Icariin given at 1680 mg/day (qd po) for 5 days

Treatment:

Drug: Icariin