DiabetesPhase 1NCT00544921
Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects
A Phase 1 study testing GLY-230 in people with Diabetes, run by Glycadia at 1 site in United States.
Trial summary
To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- GLY-230
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2006
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men age 18-55
- Negative drug screen
- Normal EKG, clinical chemistries, CBC, urinalysis, and
- Give written informed consent
Who cannot join
- Active concomitant serious medical or surgical disease,
- Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Anti-glycation Agent GLY-230
To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.
- Conditions
- Diabetes
- Being tested
- GLY-230, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLY-230Drug
PlaceboOther
No drug administered
| Study group | Role | What they receive |
|---|---|---|
| 50 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 100 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 250 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 500 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 750 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 1000 mg | Experimental | Not described Receives: Drug: GLY-230 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects
Measured: October, 2005 to October, 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycadia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Laurence Kennedy, Principal investigator, Univ. FLA Gainesville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544921
- Sponsor's protocol ID
- GLY-001
- Status last verified
- Feb 2016
- First submitted
- 15 Oct 2007
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Anti-glycation Agent GLY-230
- ClinicalTrials.gov ID
- NCT00544921
- Acronym / sponsor ID
- GLY-001
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlycadiaIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- Oct 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 16 Oct 2007 (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.
To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 50 mg | Experimental | Drug: GLY-230 |
| 100 mg | Experimental | Drug: GLY-230 |
| 250 mg | Experimental | Drug: GLY-230 |
| 500 mg | Experimental | Drug: GLY-230 |
| 750 mg | Experimental | Drug: GLY-230 |
| 1000 mg | Experimental | Drug: GLY-230 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men age 18-55
- Negative drug screen
- Normal EKG, clinical chemistries, CBC, urinalysis, and
- Give written informed consent
Key exclusion criteria (2 listed)
- Active concomitant serious medical or surgical disease,
- Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days
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 |
|---|---|---|
| GLY-230 | Drug | 100 mg, 1000 mg, 250 mg, 50 mg, 500 mg, 750 mg |
| PlaceboNo drug administered | Other | Placebo |
Primary outcome
A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects
Time frame: October, 2005 to October, 2006
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 10 Feb 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.
Laurence Kennedy principal investigator
Univ. FLA Gainesville
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 GLY-230 in people with Diabetes, run by Glycadia 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 4 inclusion and 2 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 10 Feb 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. Some participants in this study may receive a placebo. 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?
A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects (time frame: October, 2005 to October, 2006). 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 10 Feb 2016.