A Pharmacokinetics Study of Intravenous Ascorbic Acid

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534753
• Other study ID #: MGP-101
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2015
• Last updated: March 22, 2016
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: McGuff Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Ascor L 500® (Ascorbic Acid Injection, USP)
A sterile, solution containing 500 mg ascorbic acid per mL

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
McGuff Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Ascorbic Acid (µM) in plasma		1 day	No
Secondary	Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system		1 day	Yes
Secondary	Changes from Baseline in clinical laboratory and vital signs to discharge		1 day	Yes
Secondary	Changes from pre-dose physical exam findings to discharge		1 day	Yes