A Safety Study of Orally Administered BPM31510 in Healthy Subjects

This is an open-label, Phase I study of the bioavailability and safety of Berg Pharma
Molecule 31510 (BPM 31510) in healthy subjects dosed 2 or 3 times daily for 14 days. Cohort
1 and Cohort 2 will consist of 10 patients each. Men and women over the age of 18, and in
good general health, will undergo Screening and baseline evaluations up to 21 days prior to
dosing. The cohorts may be enrolled concurrently.

Subjects will be admitted to the clinic on Day 0. All subjects will self-administer the all
Day 1 doses of study drug under supervision of the clinic staff. In Cohort 1, doses 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.

In Cohort 2 doses 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.

Dosing will continue for an additional 14 days on an outpatient basis with the last study
dose to be administered at the clinic on Day 15 (ONLY MORNING DOSE IS GIVEN ON DAY 15).

On Days 1, 2, 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 for Group 1: Two Times Daily (BID) and Group 2: Three Times Daily (TID)
(with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose of TID
subjects only). Urine for PK/PD will be collected pre-dose, and 2, 4, and 8 hours post dose
on Day 1 only. At all visits (on Days 1, 2, 8,and at the final dose on Day15), samples will
be collected for chemistry, Complete Blood Count (CBC), INR, Prothrombin Time (PT), Partial
Thromboplastin Time (PTT), cholesterol, LDL, and HDL, and vitamin K level. Blood samples for
PK/PD will be collected 30 minutes prior to the last dose (AM) on Day 15 and also at 0.5, 1,
2, and 4 hours after dosing. Lab samples (chemistry, etc.), as above will also be drawn at
the time of the first PK/PD draw on Day 15.

A phone interview will be conducted no fewer than 30 days and no more than 45 days after the
last dose on Day 15 to collect information on concomitant medications and adverse events
(AEs).

Inclusion Criteria:

- 1. 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

- 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.