UMIN-CTR Clinical Trial

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
Email	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
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	Institutional Review Board of Oita University Hospital
Address	1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
Tel	097-586-6163
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039287