Clinical trial NCT02686281: Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes
Official title: A Double-Blind, Placebo-Controlled, Randomised, Two Part Study of the Safety and Pharmacokinetics of GMC-252 in A) Healthy Male Subjects, Including a Comparison of GMC-252 Dosing in the Fed and Fasted States ,and B) in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Genmedica Therapeutics S.L.
Sponsor class: INDUSTRY
Collaborators: name: Simbec Research
First posted: 2016-02-19
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) within the range of 18-35 kg/m2 inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
* Diet: Able to eat standard food, no vegetarians.
* Compliance: Understood and was willing, able and likely to comply with all study procedures and restrictions.
* Consent: Demonstrated understanding of the study and willingness to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the Informed Consent Form.
* Had no known hypersensitivity to diflunisal, NAC (N-acetylcysteine) or other non-steroidal anti-inflammatory drugs (NSAIDs).
* Had no known peptic ulcer diseases.
* Had an estimated creatinine (CREA) clearance ≥ 50 mL/min (Creatinine clearance was calculated from the serum CREA value using the Cockroft \& Gault formula).
* Had no history of heart failure or uncontrolled hypertension or other known overt cardiovascular disease.
* Had no history of 'Aspirin Triad' (chronic rhinosinusitis with polyps, severe asthma and intolerance to aspirin or other NSAIDs).
* Had no marked abnormality of liver tests before entry into the study.
* Male subject willing to use an effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse was in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
* Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values at the Screening Visit.
* Subject with a negative urinary drugs of abuse screen (a positive alcohol result could have been repeated at the discretion of the Investigator).
* Subject with negative human immunodeficiency virus (HIV) and Hepatitis B (Hep B) and Hepatitis C (Hep C) results.
* Subject with no clinically significant abnormalities in 12-lead ECG at the Screening Visit.
* Subject was available to complete the study (including all Follow-up Visits).
* Subject satisfied a medical examiner about their fitness to participate in the study.
* Subjects were non-smokers and non-alcohol drinkers or drank alcohol in moderation (e.g. ≤ 14 units/week).

Exclusion Criteria:

* A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
* Receipt of regular medication at the Screening Visit that may have had 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.
* A clinically significant history of previous allergy/sensitivity to GMC-252.
* A clinically significant history of drug or alcohol abuse.
* 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 16 weeks or a marketed drug clinical study within the previous 12 weeks. (N.B. washout period between trials 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 12 weeks.
* Receipt of any medication since the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).

Primary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Over a 14 days period post dose
Secondary outcomes:
measure: Maximal Concentration (Cmax)
timeFrame: Over a 14 days period post dose
measure: Area Under the Concentration-Time Curve
timeFrame: Over a 14 days period post dose
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Ltd
Study officials:
affiliation: Simbec Research
name: Salvatore Febbraro, MBBS
role: PRINCIPAL_INVESTIGATOR
References: