Icariin to Prevent Corticosteroid-related Memory Changes

NCT02112123 | Completed Phase 1 DMC

• 2 other identifiers: 102012-0521R21AT007869-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

the Pharmacokinetic Profile of Icariin in Humans

Keywords

icariin; pharmacokinetics; healthy participants

Outcome Measures

Primary Outcomes (1)

• Blood concentration levels of icariin

  24 hours

Secondary Outcomes (3)

• A-SEX

  5 days

• SAFTEE

  5 days

• PT/PTT levels

  5 days

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Matching placebo given for 5 days (qd po)

Dietary Supplement: Matching placebo

Icariin - 100 mg/day

ACTIVE COMPARATOR

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

Drug: Icariin

Icariin - 200 mg/day

ACTIVE COMPARATOR

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

Drug: Icariin

Icariin - 400 mg/day

ACTIVE COMPARATOR

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

Drug: Icariin

Icariin - 840 mg/day

ACTIVE COMPARATOR

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

Drug: Icariin

Icariin - 1680 mg/day

ACTIVE COMPARATOR

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

Drug: Icariin

Interventions

Icariin DRUG

Also known as: Horny Goat Weed, epimedium extract

Icariin - 100 mg/day; Icariin - 1680 mg/day; Icariin - 200 mg/day; Icariin - 400 mg/day; Icariin - 840 mg/day

Matching placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

icariin

Study Officials

• E. Sherwood Brown, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)