Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older Adults With Sarcopenia

NCT04999488 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 1665113
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to gather data on whether oral supplementation of CoQ10 is enriched in the blood and muscles in older adults with sarcopenia. This study involves 28 consecutive days of oral CoQ10 supplementation to explore changes in muscle strength, aerobic capacity and physical function with CoQ10 supplementation.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• Measurement of skeletal muscle

  We will evaluate changes in mitochondrial function (respiration) on permeabilized skeletal muscle fiber bundles obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis.

  Following 28 days of treatment

• Measurement of platelet CoQ10 level

  We will evaluate changes in mitochondrial function (respiration) on cells (platelets) obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis.

  Following 28 days of treatment

Study Arms (2)

Older adults with sarcopenia (placebo)

PLACEBO COMPARATOR

Other: Placebo

Older adults with sarcopenia (drug)

ACTIVE COMPARATOR

Drug: BPM31510

Interventions

BPM31510 DRUG

A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime.

Older adults with sarcopenia (drug)

Placebo OTHER

A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime.

Older adults with sarcopenia (placebo)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Participant must be male or female, ages 65 through 90 years of age.
• Participant must be sedentary, defined as ≤ 1 structured intentional continuous exercise session (approximately 30 mins) per week.
• Participant must be sarcopenic, defined as having a skeletal muscle mass index (SMI) of \<7.25 kg/m2 for males or \<5.67 kg/m2 for females via DEXA scan.
• Participant states willingness to follow the protocol as described and will complete any forms needed throughout the study.
• Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

You may not qualify if:

• Inability and/or unwillingness to comply with the protocol as written
• Participant has had a significant cardiovascular event (e.g., myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening. In the event of a positive stress test, participants are referred to their primary care physician. If the electrocardiogram (ECG) is determined to be a false positive, participant may be allowed to participate in study after confirmatory records obtained.
• The presence of any condition which contraindicate moderate exercise and would result in the inability to comply with the protocol as written or would compromise participant safety or data integrity, will be considered on a case-by-case basis by the Principal investigator and the study physician.
• Participant is actively pursuing weight loss and/or lifestyle changes.
• History of gastrointestinal or intracranial hemorrhage.
• History of stroke or cerebrovascular accident.
• Participant has diabetes.
• Weight stable -no gain/loss by self-report of ≥ 10 lbs in 6 months prior to screening
• BMI 40.0 kg/m2
• Untreated or poorly controlled hypertension (SBP 150, DBP 95), or hypotension (SBP 100 DBP 60)
• Participant has untreated hyperthyroidism (TSH (0.5mIU/L) or untreated hypothyroidism (TSH 10mIU/L).
• Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
• Participant is currently taking anti-inflammatory medication or has had anti-inflammatory medication within 1 week prior to screening (including over the counter formulations, e.g., Aleve, Motrin, ibuprofen, naproxen, low dose aspirin).
• Participant has had surgery requiring \> 2 days of hospitalization in the last 1 month prior to screening visit.
• Participant has an active malignancy or autoimmune disease.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Paul Coen, PhD

  AdventHealth Translational Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized, parallel arm trial in which the supplementation with oral BPM 31510 or placebo will be blind.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel arm trial in which the supplementation with oral BPM 31510 or placebo will be blind.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 10, 2021
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

US (1)