A Safety Study of Orally Administered BPM31510 in Healthy Subjects

NCT02486055 | Completed Phase 1

• 1 other identifier: BP 0312-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts may be enrolled sequentially.

Conditions

Healthy

Keywords

Study safety of BPM31510 in healthy subjects

Outcome Measures

Primary Outcomes (1)

• Cmax

  PK parameters maximum plasma concentration (Cmax) and area under the plasma concentration curve from 0 to 4 hours (AUC0-4) on Days 1, 2, 8, and 15; baseline pre-dosing concentrations.

  Days 1, 2, 8, and 15; baseline pre-dosing concentrations

Secondary Outcomes (2)

• Blood sample analysis as a measure of safety and tolerability

  Days 1, 2, 8, and 15; baseline pre-dosing concentrations

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  30 to 45 days after the end of dosing

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

In Cohort 1, doses of BPM31510 Oral Nanosuspension 4% will be administered two times per day before the morning and evening meals with no less than 8 and no more than 10 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing.

Drug: BPM31510 Oral Nanosuspension 4%

Cohort 2

ACTIVE COMPARATOR

In Cohort 2 doses BPM31510 Oral Nanosuspension 4% will be administered three times per day before meals, with no less than 4 and no more than 6 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing.

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

Cohort 1; Cohort 2

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)
• The following subjects are not required to use contraception:
• Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable)
• Female subjects with partners or male subjects who had been vasectomized at least 3 months before screening.
• Postmenopausal females who have not experienced menstruation for at least 2 years based on medical history
• Female subjects who are surgically sterile (ie, bilateral oophorectomy, hysterectomy or bilateral tubal ligation) at least 3 months before screening) based on medical history.
• Female subjects must have a negative pregnancy test result at screening and Day-1
• PT/PTT/INR within normal limits

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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: July 1, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-01

Locations

US (1)