A Pharmacokinetics Study of Intravenous Ascorbic Acid

March 22, 2016 updated by: McGuff Pharmaceuticals, Inc.

A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics of Intravenous Ascorbic Acid in Healthy Male and Female Volunteers

This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives of this study are:

  1. To evaluate the single-dose pharmacokinetics of AA administered intravenously (IV).
  2. To evaluate the safety and tolerability of AA administered intravenously.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is between the ages of 18 and 45 years, inclusive.
  • Has a body mass index (BMI) between 18 and 32 kg/m2.
  • Of sound health and has the ability to understand the requirements of the study and is willing to comply with all study requirements and procedures.

Exclusion Criteria:

  • Participates in activities that would not allow accurate evaluation of the pharmacokinetics of Ascorbic Acid
  • Medical or physical conditions that would not allow safe participation and/or accurate evaluation of the pharmacokinetics of Ascorbic Acid
  • Has participated in an investigational drug study within the 30 days prior to CRU admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single Group
Drug: Ascor L 500® (Ascorbic Acid Injection, USP)
A sterile, solution containing 500 mg ascorbic acid per mL
Other Names:
  • Ascorbic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of Ascorbic Acid (µM) in plasma
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system
Time Frame: 1 day
1 day
Changes from Baseline in clinical laboratory and vital signs to discharge
Time Frame: 1 day
1 day
Changes from pre-dose physical exam findings to discharge
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGuff Pharmaceuticals, Inc.

Investigators

  • Study Director: Damon P Jones, BS/MBA, McGuff Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (ESTIMATE)

August 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGP-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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