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A Safety Study of Orally Administered BPM31510 in Healthy Subjects

NCT02486055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-12-22

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

BPM31510 Oral Nanosuspension 4%

Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)

Sponsors & Collaborators

  • BPGbio

    lead INDUSTRY

Principal Investigators

  • Magdy Shenouda, MD · Clinilabs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486055 on ClinicalTrials.gov