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Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

NCT01786915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-04-02

No results posted yet for this study

Summary

The purpose of this study is to assess the study medication blood levels after administration of a repeat oral capsules (one capsule each day for seven days) of Bendavia at one of two dose levels. The effects of Bendavia on the volunteers will also be assessed.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Bendavia 10mg

DRUG

Bendavia 50mg

DRUG

Placebo

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Straube, MD · Stealth BioTherapeutics Inc.

  • Kenneth C Lasseter, MD · Climincal Pharmacology of Miami Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01786915 on ClinicalTrials.gov