Diabetes Mellitus, Type 2
Conditions
Interventions
This is a Phase I, single-center, randomized, placebo-controlled, parallel-group, double-blind clinical study. A total of 60 healthy adult participants of both sexes who meet the eligibility criteria
Sponsors
Synvia Laboratórios e Toxicologia Ltda.
Synvia Laboratórios e Toxicologia Ltda.
Synvia CRO Pesquisa Científica Ltda.
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Participants must be Brazilian and have Brazilian ancestry (i.e., Brazilian parents and grandparents). They may be male or female, aged between 18 and 55 years, with a body weight ranging from 60 to 100 kg and a body mass index (BMI) between 18.5 and 30 kg/m². They must be in good health, as determined by the absence of significant findings in medical history, physical examination, laboratory tests, vital signs measurements, and electrocardiogram results. Participants must be able to read, understand, and agree to take part in the study by signing the informed consent form (ICF) approved by the ethics committee. They must also agree to comply with the planned study procedures and attend all scheduled visits. Female participants must either have no potential for pregnancy—defined as postmenopausal women (with 12 months or more of amenorrhea) or those who have undergone surgical sterilization—or, if male or female with reproductive potential, must agree to use a reliable contraceptive method
Exclusion criteria
Exclusion criteria: "Participants must not belong to a vulnerable group or have difficulty swallowing solid-form medications. They must not have used any medication (including herbal remedies) within 14 days prior to hospitalization, except for contraceptives or cases where, based on the drug’s half-life and/or active metabolites, complete elimination can be assumed or, at the investigator’s discretion, the medication does not interfere with the pharmacokinetics or analytical phase of the investigational drug. They must not have used dietary supplements, including herbal or vitamin supplements, within 7 days prior to hospitalization, nor calcium or vitamin D supplements within 14 days prior. They must not have received any vaccine dose within 7 days prior to hospitalization, nor undergone treatment with any drug known to have well-defined toxic potential to major organs within the 3 months prior to the study. Participants must not have taken part in any experimental study or ingested any investigational drug within 12 months prior to the start of this study, nor have been hospitalized for any reason within 8 weeks prior to the hospitalization period. Participants must not have a history of hepatic, gastrointestinal, or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of the drug. They must not have a history of renal, urinary, respiratory, hematologic, cardiac, endocrine, gastrointestinal, neurological, neoplastic, or psychiatric diseases considered clinically significant by the investigator. They must not have a history of cardiac surgery (any type), renal surgery (removal or agenesis), gastrointestinal surgery (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid colon, or rectum), or surgery involving the liver or pancreas. Participants must not present any current, acute, or chronic symptoms or illnesses under treatment or follow-up that are considered significant by the investigator. They must not have a QTc interval greater than 450 ms (for males) or greater than 470 ms (for females), confirmed by repeat testing, or electrocardiographic findings deemed unsuitable for study participation by the physician. They must not have systolic blood pressure < 90 mmHg or > 150 mmHg, or diastolic blood pressure < 60 mmHg or > 100 mmHg during the screening visit after sitting for at least 5 minutes (and no more than 20 minutes) in a quiet, stress-free environment. Participants must not present AST or ALT results equal to or greater than 1.5 times the upper limit of the reference range, nor have laboratory test results outside reference values unless deemed not clinically significant by the investigator. They must not have lab results that, in the physician’s judgment, compromise the participant’s safety. They must not be breastfeeding, pregnant, or have a positive pregnancy test. They must not test positive on a rapid alcohol detection test or on a preliminary drug test for amphetamines/methamphetamines, opioids/morphine, cannabis/THC, cocaine/benzoylecgonine, and/or benzodiazepines. Participants must not be smokers (those with a history of smoking may be included if they have abstained for at least 3 months prior to the study). They must not have a history of illicit drug abuse or be regular alcohol consumers. Women must not consume more than 4 alcoholic drinks in a single day or more than 8 drinks per week, and me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the pharmacokinetic profile of enavogliflozin and its metabolite M1 at doses of 0.3 mg, 0.6 mg and 1.2 mg, by analysis of the parameters Cmax, Tmax, AUC0-t, AUC0-8, t½, CL/F, Vz/F, ?z and MRT after a single oral dose, and by analysis of the parameters Cmax,ss, Cav,ss, Tmax,ss, AUCtau, t½,ss, MRT, PTF, R, CLss/F, Vzss/F and ?zss after multiple oral doses, through quantification of enavogliflozin and its metabolite M1 in the blood;Evaluate the pharmacodynamic profile of enavogliflozin by analysis of urinary glucose excretion (EUG) after a single oral dose (EUG0-96) and after multiple oral doses (EUG0-24) of 0.3 mg, 0.6 mg, and 1.2 mg | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the minimum concentration (Cmin,ss) of enavogliflozin and its metabolite M1 in the blood after multiple oral doses of 0.3 mg, 0.6 mg and 1.2 mg;Evaluate blood glucose levels after single and multiple oral doses of 0.3 mg, 0.6 mg, and 1.2 mg of enavogliflozin;Evaluate the rate of occurrence of non-serious and serious adverse events, related and unrelated to doses of 0.3 mg, 0.6 mg and 1.2 mg of enavogliflozin throughout the clinical study, through data obtained in clinical and physical evaluations and laboratory tests | — |
Countries
Brazil
Contacts
Public ContactEduardo Franco
Moksha8 Brasil Indústria e Comércio de Medicamentos Ltda.
Outcome results
None listed