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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034454
Receipt No. 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 2019/03/07

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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 6
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 4mg BID, 7 daily doses
Interventions/Control_7
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 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Uemura
Organization Oita University Hospital
Division name Clinical Pharmacology Center
Zip code
Address 1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL 097-586-5952
Email uemura@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Uemura
Organization Oita University Hospital
Division name Clinical Pharmacology Center
Zip code
Address 1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL 097-586-5952
Homepage URL
Email uemura@oita-u.ac.jp

Sponsor
Institute Dept of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
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
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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