Expired Study
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Richmond, Virginia 23284


Purpose:

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


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

MGP-101


NCT ID:

NCT02534753


Secondary ID:


Study Acronym:


Brief Title:

A Pharmacokinetics Study of Intravenous Ascorbic Acid


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

McGuff Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:September 2015
Completion Date:January 2016
Completion Type:Actual
Primary Completion Date:November 2015
Primary Completion Type:Actual
Verification Date:March 2016
Last Changed Date:March 22, 2016
First Received Date:August 24, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes from pre-dose physical exam findings to discharge
Time Frame:1 day
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Changes from Baseline in clinical laboratory and vital signs to discharge
Time Frame:1 day
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system
Time Frame:1 day
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Concentration of Ascorbic Acid (µM) in plasma
Time Frame:1 day
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ascor L 500® (Ascorbic Acid Injection, USP)
Description:A sterile, solution containing 500 mg ascorbic acid per mL
Arm Name:Single Group
Other Name:Ascorbic Acid

Study Arms

Study Arm Type:Experimental
Arm Name:Single Group

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:McGuff Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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