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

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 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

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

Value
https://center6.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