the Pharmacokinetic Profile of Icariin in Humans
Conditions
Keywords
icariin, pharmacokinetics, healthy participants
Brief 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.
Detailed 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.
Interventions
DRUGIcariin
DIETARY_SUPPLEMENTMatching placebo
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration levels of icariin | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A-SEX | 5 days | Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning. |
| SAFTEE | 5 days | Systematic Assessment for Treatment Emergent Events - to assess general side effects |
| PT/PTT levels | 5 days | Prothrombin time/Partial thromboplastin time |
Countries
United States
Outcome results
None listed