Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Conditions
Interventions
EGT0001442 SR tablets, 3 mg, Single dose
EGT0001442 SR tablets, 10 mg, Cross over 2 doses
EGT0001442 SR tablets, 30 mg, Cross over 2 doses
EGT0001442 SR tablets, 90 mg, Single dose
EGT0001442 SR table
Sponsors
Integrated development Associates Co., Ltd(CTICC) Theracos Inc.(Sponsor)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1 1. Healthy, Japanese, adult, male subjects aged =>20 and <= 40 years at the time of informed consent 2. Subjects with a body mass index (BMI) of => 18.5 and <= 25.0 3. Subjects who are non-smokers for at least 6 months prior to screening 4. Subjects who are able to participate in all study-related tests and complete the study 5. Subjects who are able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines Part 2 1. Male or female Japanese subjects between the ages of 20 and 70 years 2. Subjects diagnosed with type 2 diabetes mellitus at least 12 weeks prior to screening 3. Body mass index (BMI) between 18 kg/m2 and 35 kg/m2 (inclusive) 4. HbA1c levels between 7.0 % and 10.0 % (inclusive) 5. All subjects must have a fasting plasma glucose level between 150 and 250 mg/dL (8.3 - 14 mmol/L, inclusive) at randomization 6. Male subjects and females of childbearing potential must agree to use two methods of contraception (oral contraception, diaphragm, male or female condom with spermicide, use by female sexual partner of an intrauterine device (IUD) with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, a cervical cap with spermicide) during the entire study to avoid any possible pregnancy. Females who are surgically sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses greater than 12 months) are eligible. 7. If taking medications for hypertension or hyperlipidemia, subject doses must have been stable for at least 30 days prior to enrolling in the clinical trial. 8. Subjects willing and able to comply with the investigational nature of the study, be confined to the clinical research facility, and able to communicate well with investigators. 9. Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.
Exclusion criteria
Exclusion criteria: Part 1 1. Subjects who are determined by the investigator or sub-investigator to be unsuitable for participating in the study based on medical conditions, including impairment of the central nervous system, circulatory system, respiratory system, blood/hematopoietic function system, gastrointestinal system, liver/kidney function, thyroid function, pituitary function and/or adrenal function 2. Subjects with a history of allergy to drugs or latex 3. Subjects with a history of alcohol or drug dependence 4. Subjects with a history of bladder dysfunction, such as incontinence, pollakiuria, or nocturia etc. Part 2 1. Subjects treated with anti-diabetic medication at any time within the 12 weeks prior to screening 2. Subjects having any major health problems other than type 2 diabetes, such as stroke or myocardial infarction or any conditions that required cardiac or peripheral re-vascularization procedures within the 6 months prior to screening 3. Female subjects who are pregnant, lactating, or who showed positive results in urine pregnancy test at screening etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) profile of single ascending oral doses of EGT0001442 in doses ranging from 3 to 90 mg/day in healthy, male, Japanese subjects. The safety, tolerability, PK and PD profile of multiple ascending oral doses of EGT0001442 for 7 days in Japanese subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| The food effect on the PK and PD parameters of EGT0001442 tablets in healthy Japanese subjects. The major metabolite profiles of EGT0001442 tablets in healthy Japanese subjects who are treated with the highest single dose of EGT0001442 | — |
Countries
Japan
Contacts
Public ContactYoshitaka Ando
Integrated Development Associates, Co., Ltd Clinical and Regulatory Operations
Outcome results
None listed