NCT03002935

A Safety Study of Orally Administered BPM31510 in Healthy Subjects

A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM31510 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: BPGbio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BPM31510 Oral Nanosuspension 4%	Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-12-26
• Last updated: 2017-04-05

Locations

1 site across 1 country: United States