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Completed

NCT Number: NCT02534753

A Pharmacokinetics Study of Intravenous Ascorbic Acid

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

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

About this study

The objectives of this study are:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ascor L 500® (Ascorbic Acid Injection, USP)

Drug

A sterile, solution containing 500 mg ascorbic acid per mL

Other names: Ascorbic Acid

Primary outcomes

  1. Concentration of Ascorbic Acid (µM) in plasma

    Time frame: 1 day

Secondary outcomes

  1. Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system

    Time frame: 1 day

  2. Changes from Baseline in clinical laboratory and vital signs to discharge

    Time frame: 1 day

  3. Changes from pre-dose physical exam findings to discharge

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

McGuff Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 28, 2015
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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