Clinical trial NCT03641248: Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract
Official title: Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pharmacokinetic
Primary purpose: BASIC_SCIENCE

Brief summary: Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.

Detailed description: The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.

Eligibility criteria: Inclusion Criteria:- adult (at least 18 years of age);

* diagnosed with knee osteoarthritis (OA) ;
* body mass index (BMI) of less than 40;
* willing to use only the study product, and Tramadol or Tylenol as a rescue pain medication over the course of their participation in the study;
* willing and able to monitor blood glucose levels if diabetic;
* willing to abstain from caffeine-containing drinks and food before coming into a study visit;
* able to read and understand English and have the cognitive capacity to give consent;
* willing to abstain from use of the following during participation in the study: prescription and over-the-counter non-steroidal anti-inflammatory medications, (e.g., aspirin, ibuprofen, Advil, Motrin, Nuprin, Naproxen, etc.); any dietary supplements (St. John's Wort, etc.); and, grapefruit and/or products containing it.

Exclusion Criteria:- cardiovascular disease, previous myocardial infarction, stent, coronary artery bypass graft (CABG), arrhythmia, high or low blood pressure;

* recurrent stomach upset, or gastric or duodenal ulcers;
* gallstones or gall bladder disease (cholelithiasis);
* liver or kidney disease;
* alcohol use of more than two drinks per day on a regular basis;
* Coumadin or anti-platelet drug use;
* at risk for respiratory depression, history of seizures, or taking drugs that reduce the seizure threshold or may increase the risk for development of serotonin syndrome;
* pregnant or breast feeding, or intention to become pregnant during the study;
* pronounced allergies, or known allergy to study product or corn starch (placebo);
* have had an injection to treat OA within the past three months;
* currently taking NSAIDs, unless they are willing to stop for a 1-week wash-out period;
* currently on a selective serotonin reuptake inhibitor (SSRI) but are poorly stabilized, or have evidence of suicidal ideation and/or suicide attempts in the past year; and,
* reported use during the 7 days prior to study drug administration of: prescription and over-the-counter medications (e.g., NSAIDs), and any dietary supplements; grapefruit and/or its products; and, St. John's Wort.

Primary outcomes:
measure: Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml)
timeFrame: 0.5 hour, 1 hour, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours
measure: Time to reach Cmax (h)
timeFrame: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
measure: Determination of terminal half-life of Devil's Claw, t 1/2 (h)
timeFrame: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Secondary outcomes:
measure: Change in plasma levels of harpagoside
timeFrame: 24 hours after dose of Devil's Claw
measure: Change in plasma levels of harpagide
timeFrame: 24 hours after dose of Devil's Claw
measure: Change in plasma levels of verbascoside
timeFrame: 24 hours after dose of Devil's Claw
measure: Change in levels of 8-p-coumarylharpagide
timeFrame: 24 hours after dose of Devil's Claw
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Univ of Missouri Health Care Center
state: Missouri
Study officials:
affiliation: Univ of Missouri
name: William Folk, PhD
role: PRINCIPAL_INVESTIGATOR
References: