UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034454 |
|---|---|
| Receipt number | R000039287 |
| Scientific Title | A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated doses of ART-648/TAK-648 in healthy Japanese volunteers |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2020/10/12 09:20:07 |
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Basic information
Public title
A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated doses of ART-648/TAK-648 in healthy Japanese volunteers
Acronym
Phase 1 study of ART-648/TAK-648
Scientific Title
A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated doses of ART-648/TAK-648 in healthy Japanese volunteers
Scientific Title:Acronym
Phase 1 study of ART-648/TAK-648
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated doses of ART-648/TAK-648 in healthy Japanese volunteers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety and tolerability of single and repeated doses of ART-648/TAK-648
Key secondary outcomes
- Pharmacokinetics of single and repeated doses of ART-648/TAK-648
- Pharmacodynamics of single dose of ART-648/TAK-648
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ART-648/TAK-648 1mg, Single dose
Interventions/Control_2
ART-648/TAK-648 2mg, Single dose
Interventions/Control_3
ART-648/TAK-648 4mg, Single dose
Interventions/Control_4
ART-648/TAK-648 8mg, Single dose
Interventions/Control_5
ART-648/TAK-648 2mg BID, 7 daily doses
Interventions/Control_6
ART-648/TAK-648 2-4mg BID, 7 daily doses
Interventions/Control_7
ART-648/TAK-648 2-6mg BID, 13 daily doses
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are aged between 20 and 45 years old, at the time of Informed Consent
2. Subjects who agree that refraining from sexual activity or combining two or more suitable contraceptive methods in observation period
3. Body Mass Index (BMI) between 18.5 kg/m2 and 30.0 kg/m2 (exclusive) , and with weight over 40 kg at screening
4. Subjects judged healthy by the Investigator by all the examination results
5. Have given written informed consent after receiving sufficient explanation upon participation in the study
Key exclusion criteria
1. Have a significant complication which may affect drug evaluation, such as digestive, liver, musculoskeletal, respiratory, brain, cardiovascular, blood, tumor, endocrine, immune, nervous, psychiatric, urogenital diseases
2. Subjects who have complications or history of kidney disease
3. Subjects who have complications or history of liver disease
4. Subjects who have a history of surgical operations or medical disorders judged by the investigator that may affect the absorption, distribution, metabolism, excretion of the drug
5. Subjects who used drugs or herbal medicine products within 2 weeks before the investigational drug administration or who may need such drugs
6. Subjects who ingested grapefruit, oranges or apples and juice or foods containing them within 72 hours before the investigational drug administration
7. Subjects who took alcohol exceeding 10 units per week
8. Subjects who habitually ingest coffee, tea, green tea, cola, other caffeinated beverages exceeding 6 cups per day
9. Smokers or subjects who smoked or used nicotine containing products within 6 months before the screening test
10. Subjects who collected 400 mL or more of blood within 12 weeks or collected 200 mL of blood within 4 weeks or donated blood component within 2 weeks before the study drug administration, or subjects who collected more than 1200 mL of blood per year
11. Participation in a clinical trial of an investigational drug within 4 months or of an approved drug within 3 months before the first drug administration
12. Have surgical operations for 4 weeks before screening tests
13. Subjects with a history of severe or multiple allergies, or with a history of hypersensitivity reaction to drugs
14. Have a history of drug or alcohol abuse
15. Subjects with significant electrocardiogram abnormalities, including QTcF> 450 msec in screening tests
16. Positive for immunological test
17. Women who are or may be pregnant, who are lactating
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Uemura |
Organization
Oita University Hospital
Division name
Clinical Pharmacology Center
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL
097-586-5952
uemura@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Uemura |
Organization
Oita University Hospital
Division name
Clinical Pharmacology Center
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL
097-586-5952
Homepage URL
uemura@oita-u.ac.jp
Sponsor or person
Institute
Dept of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
ARTham Therapeutics 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
Institutional Review Board of Oita University Hospital
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
Tel
097-586-6163
gcrcjimu@oita-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
44
Results
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
| 2018 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039287
