PharmacokineticsPhase 1NCT02534753
A Pharmacokinetics Study of Intravenous Ascorbic Acid
A Phase 1 study testing Ascor L 500® (Ascorbic Acid Injection, USP) in people with Pharmacokinetics, run by McGuff Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Ascor L 500® (Ascorbic Acid Injection, USP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
Official title: A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics of Intravenous Ascorbic Acid in Healthy Male and Female Volunteers
This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid.
Read the 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.
- Conditions
- Pharmacokinetics
- Being tested
- Ascor L 500® (Ascorbic Acid Injection, USP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascor L 500® (Ascorbic Acid Injection, USP)Drug
Also called Ascorbic Acid
A sterile, solution containing 500 mg ascorbic acid per mL
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Not described Receives: Drug: Ascor L 500® (Ascorbic Acid Injection, USP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Ascorbic Acid (µM) in plasma
Measured: 1 day
Secondary outcomes (3)
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system
Measured: 1 day
Changes from Baseline in clinical laboratory and vital signs to discharge
Measured: 1 day
Changes from pre-dose physical exam findings to discharge
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGuff Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damon P Jones, BS/MBA, Study director, McGuff Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534753
- Sponsor's protocol ID
- MGP-101
- Status last verified
- Mar 2016
- First submitted
- 24 Aug 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics of Intravenous Ascorbic Acid in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02534753
- Acronym / sponsor ID
- MGP-101
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McGuff Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Drug: Ascor L 500® (Ascorbic Acid Injection, USP) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascor L 500® (Ascorbic Acid Injection, USP)Also: Ascorbic AcidA sterile, solution containing 500 mg ascorbic acid per mL | Drug | Single Group |
Primary outcome
Concentration of Ascorbic Acid (µM) in plasma
Time frame: 1 day
3 secondary outcomes
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) grouped by body system
Time frame: 1 day
Changes from Baseline in clinical laboratory and vital signs to discharge
Time frame: 1 day
Changes from pre-dose physical exam findings to discharge
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon P Jones, BS/MBA study director
McGuff Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ascor L 500® (Ascorbic Acid Injection, USP) in people with Pharmacokinetics, run by McGuff Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Ascorbic Acid (µM) in plasma (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.