UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012713 |
|---|---|
| Receipt number | R000014634 |
| Scientific Title | A Phase I, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EGT0001442 In Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2013/12/27 |
| Last modified on | 2015/03/25 14:43:20 |
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Basic information
Public title
A Phase I, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EGT0001442 In Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Acronym
A Phase I study for EGT0001442 in Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Scientific Title
A Phase I, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EGT0001442 In Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Scientific Title:Acronym
A Phase I study for EGT0001442 in Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Region
| Japan |
Condition
Condition
Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine 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.
To evaluate the safety, tolerability, PK and PD profile of multiple ascending oral doses of EGT0001442 for 7 days in Japanese subjects
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
7
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
EGT0001442 SR tablets, 3 mg, Single dose
Interventions/Control_2
EGT0001442 SR tablets, 10 mg, Cross over 2 doses
Interventions/Control_3
EGT0001442 SR tablets, 30 mg, Cross over 2 doses
Interventions/Control_4
EGT0001442 SR tablets, 90 mg, Single dose
Interventions/Control_5
EGT0001442 SR tablets, 3 mg, 7 daily doses
Interventions/Control_6
EGT0001442 SR tablets,10 mg, 7 daily doses
Interventions/Control_7
EGT0001442 SR tablets, 3 mg, 7 daily doses
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Furihata |
Organization
P-One Clinic, Keikokai Medical Corporation
Division name
Internal Medicine
Zip code
Address
View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
TEL
042-625-5216
furihata@p1-clinic.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Ando |
Organization
Integrated Development Associates, Co., Ltd
Division name
Clinical and Regulatory Operations
Zip code
Address
Selon Building, 11-7 Shinsen Shibuya-ku, Tokyo
TEL
03-6416-0540
Homepage URL
yoshitaka.ando@i-d-a.com
Sponsor or person
Institute
Integrated development Associates Co., Ltd(CTICC)
Theracos Inc.(Sponsor)
Institute
Department
Personal name
Funding Source
Organization
Theracos Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団 慶幸会 ピーワンクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The PK and PD parameters for EGT0001442 are similar between American and Japanese populations. Administration of EGT0001442 to Japanese subjects was safe and well tolerated. Prior consumption of food was not found to markedly change the PK parameters observed following administration of the 10 and 30 mg dosage forms. EGT0001442 reduced fasting plasma glucose in Japanese volunteers with T2DM. The results of this study provide justification for the further clinical development of EGT0001442 in Japan.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 27 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 27 | Day |
Last modified on
| 2015 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014634
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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