A Safety Study of Orally Administered BPM31510 in Healthy Subjects

Study subjects will be admitted to the clinic on Day -1. All subjects will self-administer
the Day 1 doses of study drug under supervision of the clinic staff. Doses of 3200 mg will
be administered three times per day before meals.

Dosing will continue for an additional 14 days on an outpatient basis with Day 5 morning
dose and the last study dose on Day 15 to be administered at the clinic (one morning dose,
is given on Day 15).

On Days 1, 2, 5 and 15, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be
performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first
dose at all visits with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second
dose. Urine for PK/PD will be collected pre-dose on Day 1, Day 2, Day 5 and Day 15. At all
visits (on Days 1, 2, 5 and at the final dose on Day 15), samples will be collected for
chemistry, Complete Blood Count (CBC), International normalized ratio (INR), prothrombin
time (PT), partial thromboplastin time (PTT), cholesterol, low density lipoprotein (LDL),
and high density lipoprotein (HDL), and vitamin K level. Blood samples for PK/PD will be
collected 30 minutes prior to the morning dose on Day 5 and Day 15 and also at 0.5, 1, 2,
and 4 hours after dosing. Lab samples (chemistry, etc.), will also be drawn at the time of
the first PK/PD draw on Day 5 and Day 15.

A phone interview will be conducted no fewer than 25 days and no more than 35 days after the
last dose on Day 15 to collect information on concomitant medications and adverse events
Graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Participation in any experimental study or ingested any experimental drug within 30
days preceding study

- Donation or loss of 450 mL or more of blood within the 3 months prior to
Screening/Baseline

- Subject consumed alcohol 48 hours prior to the baseline measurements of the study

- Subject reports history of human immunodeficiency virus

- Currently using coenzyme Q10 over-the-counter products