A Safety Study of Orally Administered BPM31510 in Healthy Subjects

NCT03002935 | Completed Phase 1

• 1 other identifier: BP 0312-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Phase I study of the bioavailability and safety of BPM31510 administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax)

  Pharmacokinetic (PK) samples collected to establish oral bioavailability.

  Days 1, 2, 5, 15; baseline pre-dosing concentrations

• Area under the plasma concentration curve (AUC0-4)

  Pharmacokinetic (PK) samples collected to establish oral bioavailability.

  Days 1, 2, 5, 15; baseline pre-dosing concentrations

Secondary Outcomes (5)

• Number of study subjects with adverse events

  Baseline to 25-35 days after the end of dosing

• C-reactive protein measurement

  Days 1, 2, 5, 15

• Cholesterol measurement

  Days 1, 2, 5, 15

• Low density lipoprotein (LDL) measurement

  Days 1, 2, 5, 15

• High density lipoprotein (HDL) measurement

  Days 1, 2, 5, 15

Study Arms (1)

BPM31510 Oral Nanosuspension 4%

EXPERIMENTAL

Study subjects will self-administer 80 mL (4 vials of 20 mL) of oral BPM31510 (Ubidecarenone, USP; 40 mg/mL) nano-suspension 3 times daily every 4 to 6 hours for a total daily dose 9600 mg/day of BPM31510 for 14 consecutive days. The last study dose (morning dose only) is administered at the clinic on Day 15.

Drug: BPM31510 Oral Nanosuspension 4%

Interventions

BPM31510 Oral Nanosuspension 4% DRUG

Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)

Also known as: Coenzyme Q10, CoQ10, ubidecarenone

BPM31510 Oral Nanosuspension 4%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age \>18 years
• Body mass index (BMI)≥19 and ≤30
• Good health conditions or without significant illness, by judgment of a legally qualified professional, according to the following evaluations: medical history, physical examination, vital signs, electrocardiogram (ECG), and screening or baseline hematology and clinical chemistry measures.
• Subjects of child bearing potential must agree to use one of the accepted methods of contraception (listed below) during the trial (including the screening period prior to receiving trial medication), at least until return of menstruation after stopping the trial medication.
• condom (male or female) with spermicide
• diaphragm or cervical cap with spermicide
• Intrauterine device (IUD)
• hormonal contraception and condom (male or female)
• Female subjects must have a negative pregnancy test result at screening and Day-1
• PT/PTT/INR within normal limits
• Vitamin K levels within normal limits
• Capable of understanding and complying with the protocol and signing informed consent

You may not qualify if:

• Pregnant or lactating female subjects
• Known hypersensitivity to the study drug (Coenzyme Q10) or to compounds chemically related
• History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes with the drug's absorption, distribution, excretion or metabolism
• History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric illness
• Hypotension or hypertension of any etiologic that needs pharmacologic treatment
• History of or existing coagulopathy
• History of myocardial infarction, angina, and/or heart insufficiency
• Non-recommended electrocardiographic findings, according to investigator criteria
• Results of the laboratory exams out of normal range unless that they are considered as clinically irrelevant by the investigator
• Subject is a smoker
• Subject ingests more than 5 cups of coffee or tea a day
• History of alcohol or drug abuse
• History of serious adverse reactions or hypersensitivity to any drug
• On-going regular use of oral prescription drugs, with the exception of oral contraceptives
• Hospitalization for any reason within 8 weeks prior to study dosing

Sponsors & Collaborators

• BPGbio: lead

Study Sites (1)

Clinilabs Inc.

Eatontown, New Jersey, 07724, United States

Location

MeSH Terms

Interventions

coenzyme Q10

Study Officials

• Magdy Shenouda, MD

  Clinilabs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 26, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)