NCT02534753

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

August 24, 2015

Last Update Submit

March 22, 2016

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Concentration of Ascorbic Acid (µM) in plasma

    1 day

Secondary Outcomes (3)

  • 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

  • Changes from pre-dose physical exam findings to discharge

    1 day

Study Arms (1)

Single Group

EXPERIMENTAL
Drug: Ascor L 500® (Ascorbic Acid Injection, USP)

Interventions

Ascor L 500® (Ascorbic Acid Injection, USP)DRUG

A sterile, solution containing 500 mg ascorbic acid per mL

Also known as: Ascorbic Acid
Single Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Damon P Jones, BS/MBA

    McGuff Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 28, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

US(1)