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A Safety Study of Orally Administered BPM31510 in Healthy Subjects

NCT03002935 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-04-05

No results posted yet for this study

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.

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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT03002935 on ClinicalTrials.gov