Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract

Osteoarthritis, Knee Clinical Trial

Official title:

Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03641248
• Other study ID #: 2010425
• Secondary ID: US NIH Grant 7R2
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: May 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2022
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Drug:
• Enteric coated Devil's Claw
Enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
• Non-enteric coated Devil's Claw
Non-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside

Locations

Country	Name	City	State
United States	Univ of Missouri Health Care Center	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml)	Blood will be drawn at predefined intervals following administration of one dose of study drug	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
Primary	Time to reach Cmax (h)	Blood will be drawn at predefined intervals following administration of one dose of study drug	0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Primary	Determination of terminal half-life of Devil's Claw, t 1/2 (h)	Blood will be drawn at predefined intervals following administration of one dose of study drug	0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Secondary	Change in plasma levels of harpagoside	Blood will be drawn for Devil's Claws metabolites at Visit 2	24 hours after dose of Devil's Claw
Secondary	Change in plasma levels of harpagide	Blood will be drawn for Devil's Claws metabolites at Visit 2	24 hours after dose of Devil's Claw
Secondary	Change in plasma levels of verbascoside	Blood will be drawn for Devil's Claws metabolites at Visit 2	24 hours after dose of Devil's Claw
Secondary	Change in levels of 8-p-coumarylharpagide	Blood will be drawn for Devil's Claws metabolites at Visit 2	24 hours after dose of Devil's Claw