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 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.

Key facts

Study ID

NCT02486055

Run by

BPGbio

People needed

20

Starts

2015-11-01

Expected to finish

2016-01-01

Last updated by the study team

2016-12-22

Who can join

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

You may qualify if…

• 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.

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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