Impaired Glucose TolerancePhase 1LIMNCT01093677
Investigation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance
A Phase 1 study testing LIM-0705 in people with Impaired Glucose Tolerance, run by Limerick BioPharma.
Trial summary
LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- LIM-0705
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jul 2010
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, age 18-70 years old
- Measured waist circumference to hip circumference ratio >0.90
- Body mass index (BMI) of 27 - 40 kg/m2
- Screening and Day -1 capillary glucose measurement between 110-160 mg/dL (6.1-8.9 mmol/L) after a 12 hour fast
- Screening and Day -1 OGTT with a 2 hour post-glucose measurement ≥140 mg/dL (7.8 mmol/L) after a 12 hour fast
- Screening HbA1c > 6 and ≤ 7.5%
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- Subjects must be in reasonably good health as determined by pre-study medical history, physical examination, 12-lead ECG, and the following laboratory measures:
- Electrolytes, ALP, LDH, creatinine, and urea must be within normal range without medication
- Urinalysis within normal limits
- Willing to remain in confinement at the clinical study unit for up to 18 days/17 nights and to return to the unit as specified for additional assessments
- Willing to consume only the food that is provided by the clinical study unit
- Non-smokers or "social smokers" (defined as fewer than 5 cigarettes per week) willing to abstain from smoking for the duration of study
- Willing to abstain from alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages
- Able to read, understand and follow the study instructions
- Agree to use of two effective methods of contraception
Who cannot join
- Allergy to onions or red wine
- Strict vegetarians (i.e., subjects who do not eat meat, fish, fowl, or dairy)
- Use of any non-study medication(s) during the study period other than those approved by the Investigator for treatment of an adverse event (AE)
- Use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within five (5) years prior to the Screening visit
- Use of any dietary aids or foods known to modulate drug metabolizing enzymes (e.g., St. John's Wort, grapefruit juice) within 4 days of randomization
- History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 30 days of randomization
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- Difficulty in swallowing oral medications
- History of seizure disorder
- Moderate to severe gastro-esophageal reflux disease
- History of arrhythmia
- Cognitive or psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit
- Baseline liver enzymes greater than the upper limit of normal
- Baseline creatine phosphokinase (CPK) greater than 2.5x the upper limit of normal
- History of drug or alcohol abuse
- Use of any other investigational drug within 30 days of randomization or investigational biologic within 180 days of randomization
- Use of over-the-counter (OTC) medications or nutraceuticals, excluding routine vitamins, within 14 days of randomization or 5 half-lives of the drug, whichever is longer
- Use of prescription pharmaceuticals within 30 days of randomization
- Donation and/or receipt of any blood or blood products within 90 days of randomization
- Current gastrointestinal (GI), renal, hepatic, or coagulant disorder within 12 months of randomization
- History of peptic or duodenal ulcer or GI bleed
- Subjects with Gilbert's Syndrome
- Subjects with positive drug or alcohol screen
- Subject positive for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
About this study
Official title: A Single-Blind,Randomized,Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance
LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance
- Conditions
- Impaired Glucose Tolerance
- Being tested
- LIM-0705, Placebo
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIM-0705Drug
Oral solution 750 mg LIM 0705 BID for 14 days.
PlaceboDrug
Oral solution placebo BID for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 750 mg of LIM-0705 BID for 14 days. Up to 20 subjects. Receives: Drug: LIM-0705 |
| B | Placebo comparator | Placebo BID for 14 days. Up to 10 subjects. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of LIM-0705 on glucose metabolism, lipid metabolism and renal function in subjects with impaired glucose tolerance
- Assessment of glucose metabolism will be based on monitoring of overnight-fasting glucose levels and on performance of an Oral Glucose Tolerance Test (OGTT)
- Assessment of lipid metabolism will be based on 12 hour-fasting lipid profiles (including LDL, HDL, total cholesterol, free fatty acids, and triglycerides)
- Assessment of renal function will be performed by monitoring serum BUN and creatinine levels
Measured: approx. 1 month
Secondary outcomes (1)
Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite
- To evaluate the incidence of treatment emergent adverse events; as well as changes in physical examination findings, vital signs, ECGs, and clinical laboratory tests (serum chemistry, hematology urinalysis, and coagulation)
- To characterize the pharmacokinetics of LIM-0705 and its major metabolite
Measured: approx. 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Why it stopped: no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limerick BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Albert Frauman, MD, Study director, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093677
- Sponsor's protocol ID
- LIM-0705-CL-003
- Acronym
- LIM
- Status last verified
- Jun 2010
- First submitted
- 15 Mar 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind,Randomized,Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 in Male Subjects With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT01093677
- Acronym / sponsor ID
- LIM / LIM-0705-CL-003
- Conditions
- Impaired Glucose Tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subjects enrolled
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Limerick BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 26 Mar 2010 (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.
LIM-0705 will gain results on the effects of LIM-0705 on Male Subjects with Impaired Glucose Tolerance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LIM-0705750 mg of LIM-0705 BID for 14 days. Up to 20 subjects. |
| B | Placebo comparator | Drug: PlaceboPlacebo BID for 14 days. Up to 10 subjects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males, age 18-70 years old
- Measured waist circumference to hip circumference ratio >0.90
- Body mass index (BMI) of 27 - 40 kg/m2
- Screening and Day -1 capillary glucose measurement between 110-160 mg/dL (6.1-8.9 mmol/L) after a 12 hour fast
- Screening and Day -1 OGTT with a 2 hour post-glucose measurement ≥140 mg/dL (7.8 mmol/L) after a 12 hour fast
Key exclusion criteria (23 listed)
- Allergy to onions or red wine
- Strict vegetarians (i.e., subjects who do not eat meat, fish, fowl, or dairy)
- Use of any non-study medication(s) during the study period other than those approved by the Investigator for treatment of an adverse event (AE)
- Use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within five (5) years prior to the Screening visit
- Use of any dietary aids or foods known to modulate drug metabolizing enzymes (e.g., St. John's Wort, grapefruit juice) within 4 days of randomization
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 |
|---|---|---|
| LIM-0705Oral solution 750 mg LIM 0705 BID for 14 days. | Drug | A |
| PlaceboOral solution placebo BID for 14 days. | Drug | B |
Primary outcome
To evaluate the effect of LIM-0705 on glucose metabolism, lipid metabolism and renal function in subjects with impaired glucose tolerance
Time frame: approx. 1 month
* Assessment of glucose metabolism will be based on monitoring of overnight-fasting glucose levels and on performance of an Oral Glucose Tolerance Test (OGTT) * Assessment of lipid metabolism will be based on 12 hour-fasting lipid profiles (including LDL, HDL, total cholesterol, free fatty acids, and triglycerides) * Assessment of renal function will be performed by monitoring serum BUN and creatinine levels
1 secondary outcome
Incidence of treatment emergent adverse events and pharmacokinetics of LIM-0705 and its major metabolite
Time frame: approx. 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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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.
Albert Frauman, MD study director
Nucleus Network
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIM-0705 in people with Impaired Glucose Tolerance, run by Limerick BioPharma.
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 15 inclusion and 23 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: withdrawn, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the effect of LIM-0705 on glucose metabolism, lipid metabolism and renal function in subjects with impaired glucose tolerance (time frame: approx. 1 month). 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 8 Jun 2010.