A Safety Study of Orally Administered BPM31510 in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03002935

Run by

BPGbio

People needed

25

Starts

2017-01-01

Expected to finish

2017-03-01

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Clinilabs Inc. — Eatontown, New Jersey, United States

Full record on ClinicalTrials.gov

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