A Pharmacokinetics Study of Intravenous Ascorbic Acid | NCT02534753

Studies
A Pharmacokinetics Study of Intravenous Ascorbic Acid

NCT02534753

Sponsor

McGuff Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Mar 23, 2016Estimated

Enrollment

8Actual

Phase

Phase 1

Conditions

Pharmacokinetics

Interventions

Ascor L 500® (Ascorbic Acid Injection, USP)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Aug 24, 2015

First Submission Date that Met QC Criteria

Aug 25, 2015

First Posted Date

Aug 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2016

Last Update Posted Date

Mar 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Group	Experimental		Drug: Ascor L 500® (Ascorbic Acid Injection, USP)

Interventions

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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Damon P Jones, BS/MBA	McGuff Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23284	United States

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided