Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract

NCT03641248 | Withdrawn Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2010425US NIH Grant 7R21AT009086
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Change in plasma levels of harpagoside

  24 hours after dose of Devil's Claw

• Change in plasma levels of harpagide

  24 hours after dose of Devil's Claw

• Change in plasma levels of verbascoside

  24 hours after dose of Devil's Claw

• Change in levels of 8-p-coumarylharpagide

  24 hours after dose of Devil's Claw

Study Arms (2)

Enteric coated Devil's Claw

EXPERIMENTAL

H. procumbens 100 mg in enteric coated capsules

Drug: Enteric coated Devil's Claw

Non-enteric coated Devil's Claw

ACTIVE COMPARATOR

H. procumbens 100 mg in non-enteric coated capsules

Drug: Non-enteric coated Devil's Claw

Interventions

Enteric coated Devil's Claw DRUG

Enteric coated capsules containing Devil's Claw extract with 100mg harpagoside

Also known as: Harpagophytum procumbens

Enteric coated Devil's Claw

Non-enteric coated Devil's Claw DRUG

Non-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside

Also known as: Harpagophytum procumbens

Non-enteric coated Devil's Claw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Univ of Missouri Health Care Center

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Harpagophytum extract LI 174

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William Folk, PhD

  Univ of Missouri

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Pharmacokinetic

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: May 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)