HealthyPhase 1NCT02744820
Multiple Ascending Dose Study of GMC-252-L-Lys Salt in Healthy Subjects and Type 2 Diabetics
A Phase 1 study testing GMC-252-L-Lysine Salt in people with Healthy and Type 2 Diabetes Mellitus, run by Genmedica Therapeutics S.L. at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2 diabetics. 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
- Healthy, Type 2 Diabetes Mellitus
- What is being tested?
- GMC-252-L-Lysine Salt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2016to Sep 2017
- 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
- Part 1 (Healthy Subjects) and Part 2 (Type 2 Diabetic Patients):
- Diet: Able to eat standard food, no vegetarians.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Consent: Demonstrates understanding of the study and has given signed, voluntary written informed consent.
- Have no known hypersensitivity to diflunisal, NAC or other NSAIDs.
- No history of blood diseases including but not limited to clinically significant platelet diseases and coagulation abnormalities.
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- No clinically relevant gastrointestinal disease.
- Have an estimated creatinine (CREA) clearance>70 mL/min/surface area (CREA clearance will be calculated from the serum CREA value by using the Cockroft and Gault formula).
- Have no history of heart failure or uncontrolled hypertension or other known clinically significant cardiovascular disease.
- Have no history of bronchial asthma or 'Aspirin Triad' (chronic rhino-sinusitis with polyps, severe asthma and intolerance to aspirin or other NSAIDs).
- Have no clinically significant abnormality of liver tests before entry into the study.
- A negative urinary drugs of abuse screen, determined within 28 days before the first dose (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
- Negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
- No clinically significant abnormalities in a 12-lead ECG determined within 28 days before the first dose.
- No history of clinically significant renal disease or any food intolerance.
- Willing to use 2 effective methods of contraception i.e. established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
- Additional Criteria for Part 1 (Healthy Subjects):
- Healthy males aged 18 to 55 inclusive.
- Body mass index (BMI) within the range of 18-30 kg/m2 inclusive.
- Non-Smokers (including e-cigarettes) who have abstained from smoking for at least 6 months.
- Additional Criteria for Part 2 (Type 2 Diabetic Patients):
- Males aged 18 to 65 inclusive. BMI within the range of 18-38 kg/m2 inclusive.
- Diagnosis of T2DM according to the World Health Organization criteria.
- HbA1c between 7.0% and 12.0 % inclusive.
- Currently treated with metformin with a stable treatment regimen for 3 months or more prior to the Screening Visit, and not receiving other anti-diabetic medications. Allowed medication during the study include metformin, statin (3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibitors), paracetamol up to 3 g/day, low doses of aspirin and antihypertensive drugs if the doses are not changed in the 3 months before the start of screening. Other allowed medications will be approved by PI and Sponsor before a patient can be enrolled. Diflunisal (a test drug component) may decrease the antihypertensive activityof many of the currently used antihypertensive medications, such as β-blockers, alpha (α)-blockers, loop diuretics, angiotensin converting enzyme (ACE inhibitors), angiotensin 2 receptor blockers, calcium channel blockers. Therefore, patients who are on current stable antihypertensive medications will be subjected to close monitoring of their blood pressure throughout the study.
- Stable dietary habits and regimen of treatment for concomitant diseases for 1 month or more prior to the Screening Visit.
- Subject able and willing to undergo oral glucose tolerance test (OGTT).
Who cannot join
- Part 1 (Healthy Subjects) and Part 2 (Type 2 Diabetic Patients):
- A clinically significant history of previous allergy / sensitivity to any of the GMC-252 components, NAC or diflunisal.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Donation of 450 mL or more blood within the previous 3 months.
- A clinically significant history of drug, alcohol or other substance abuse in the past 2 years.
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- Additional Criteria for Part 1 (Healthy Subjects):
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 28days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Additional Criteria for Part 2 (Type 2 Diabetic Patients):
- Diagnosis/General Health:
- Diabetic autonomic or sensory neuropathy including gastroparesis, diabetic nephropathy or untreated active proliferative retinopathy.
- Clinically significant abnormalities in laboratory evaluation (including clinical biochemistry, haematology and urinalysis) in the opinion of the Investigator.
- Diseases:
- Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg), severe or unstable angina, coronary insufficiency, congestive heart failure, clinically significant (in the opinion of the Investigator) renal or hepatic disease.
- Previous gastric or intestinal surgerythat might impact drug absorption.
- Malignancy within 5 years of the start of the study, except for successfully treated local basal cell carcinoma
- Current or relevant previous history, of clinically significant psychiatric illness.
- Medications:
- Current use of insulin or any previous use of insulin other than as part of a clinical trial or associated with surgical procedure or acute illness for up to 7 days.
- Use of any anti diabetic medication other than metformin in the 3 months prior to study entry.
- Current use of any anticoagulant drug e.g. warfarin, heparin.
- Prior use (within 48 h of dosing) of any drug that could have altered gastric motility (domperidone, cyclizine, metoclopramide, prochlorperazine), or cholestyramine.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
BioKinetic Europe Ltd.
Belfast, BT2 7BA
Simbec Research Ltd
Merthyr Tydfil, CF48 4DR
About this study
Official title: A Double Blind, Placebo-controlled, Randomised, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GMC-252 in Healthy Male Subjects and Male Type 2 Diabetics
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2 diabetics.
The secondary objective is to explore the effect of multiple oral doses of GMC-252 on pharmacodynamic(PD) parameters in type 2 diabetics.
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Being tested
- GMC-252-L-Lysine Salt, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMC-252-L-Lysine SaltDrug
Also called GMC-252-L-Lys Salt
1 dose by oral route, once a day, 28 days
PlaceboOther
Matching doses by oral route, once a day, 28 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Part 1) | Placebo comparator | Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo Receives: Drug: GMC-252-L-Lysine Salt; Other: Placebo |
| Cohort 2 (Part 1) | Placebo comparator | Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo Receives: Drug: GMC-252-L-Lysine Salt; Other: Placebo |
| Cohort 3 (Part 1) | Placebo comparator | Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo Receives: Drug: GMC-252-L-Lysine Salt; Other: Placebo |
| Cohort 4 (Part 2) | Placebo comparator | Multiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo
Interventions:
Drug: GMC-252-L-Lysine Salt Other: Placebo Receives: Drug: GMC-252-L-Lysine Salt; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
Measured: 28 days plus 14 days post last dose
Secondary outcomes (3)
Maximal Concentration (Cmax)
Measured: 28 days plus 14 days post last dose
Area Under the Concentration-Time Curve
Measured: 28 days plus 14 days post last dose
Time to reach steady state
Measured: 28 days plus 14 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: It was considered by the sponsor that the study objective has been met by dosing 13 instead of 15 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmedica Therapeutics S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Robert Adams, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744820
- Sponsor's protocol ID
- GMC-252-1.03
- Status last verified
- Oct 2017
- First submitted
- 13 Apr 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-controlled, Randomised, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GMC-252 in Healthy Male Subjects and Male Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT02744820
- Acronym / sponsor ID
- GMC-252-1.03
- Conditions
- Healthy, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was considered by the sponsor that the study objective has been met by dosing 13 instead of 15 patients
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Genmedica Therapeutics S.L.Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 Apr 2016 (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.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2 diabetics.
The secondary objective is to explore the effect of multiple oral doses of GMC-252 on pharmacodynamic(PD) parameters in type 2 diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Part 1) | Placebo comparator | Drug: GMC-252-L-Lysine Salt, Other: PlaceboMultiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo |
| Cohort 2 (Part 1) | Placebo comparator | Drug: GMC-252-L-Lysine Salt, Other: PlaceboMultiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo |
| Cohort 3 (Part 1) | Placebo comparator | Drug: GMC-252-L-Lysine Salt, Other: PlaceboMultiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo |
| Cohort 4 (Part 2) | Placebo comparator | Drug: GMC-252-L-Lysine Salt, Other: PlaceboMultiple ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo Interventions: Drug: GMC-252-L-Lysine Salt Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- Diet: Able to eat standard food, no vegetarians.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Consent: Demonstrates understanding of the study and has given signed, voluntary written informed consent.
- Have no known hypersensitivity to diflunisal, NAC or other NSAIDs.
- No history of blood diseases including but not limited to clinically significant platelet diseases and coagulation abnormalities.
Key exclusion criteria (24 listed)
- A clinically significant history of previous allergy / sensitivity to any of the GMC-252 components, NAC or diflunisal.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Donation of 450 mL or more blood within the previous 3 months.
- A clinically significant history of drug, alcohol or other substance abuse in the past 2 years.
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 |
|---|---|---|
| GMC-252-L-Lysine SaltAlso: GMC-252-L-Lys Salt1 dose by oral route, once a day, 28 days | Drug | Cohort 1 (Part 1), Cohort 2 (Part 1), Cohort 3 (Part 1), Cohort 4 (Part 2) |
| PlaceboMatching doses by oral route, once a day, 28 days | Other | Cohort 1 (Part 1), Cohort 2 (Part 1), Cohort 3 (Part 1), Cohort 4 (Part 2) |
Primary outcome
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 28 days plus 14 days post last dose
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
3 secondary outcomes
Maximal Concentration (Cmax)
Time frame: 28 days plus 14 days post last dose
Area Under the Concentration-Time Curve
Time frame: 28 days plus 14 days post last dose
Time to reach steady state
Time frame: 28 days plus 14 days post last dose
Results and safety
The study was stopped early (reason given: It was considered by the sponsor that the study objective has been met by dosing 13 instead of 15 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Robert Adams, MBBS principal investigator
Simbec Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMC-252-L-Lysine Salt in people with Healthy and Type 2 Diabetes Mellitus, run by Genmedica Therapeutics S.L. at 2 sites in United Kingdom.
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 27 inclusion and 24 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: stopped early, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 was stopped early (reason given: It was considered by the sponsor that the study objective has been met by dosing 13 instead of 15 patients). Results are not available in the source record.
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?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: 28 days plus 14 days post last dose). 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 12 Oct 2017.