| Trial registration number
|
JPRN-jRCT2051200153 |
Full text link
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
https://jrct.niph.go.jp/latest-detail/jRCT2051200153
|
First author
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Contact for Clinical Trial Information
|
Contact
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
dsclinicaltrial@daiichisankyo.co.jp
|
Registration date
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2021-03-12
|
Recruitment status
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
|
Allocation
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Randomized
|
Design
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Blind label
|
Center
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
unclear
|
Study aim
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Prevention
|
Inclusion criteria
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Japanese healthy male subjects.2. Age >=20 and <=45 years upon providing informed consent.3. Body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening.
|
Exclusion criteria
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence etc.
|
Number of arms
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Inoguchi Akihiro
|
Inclusion age min
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
20
|
Inclusion age max
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
45
|
Countries
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Japan
|
Type of patients
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Healthy volunteers
|
Severity scale
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
N/A
|
Total sample size
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
76
|
primary outcome
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Safety:AEs; laboratory data; body weight; vital signs; 12-lead ECGs; and chest X-ray
|
Notes
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
|
Phase
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Phase 1
|
Arms
Last imported at : March 31, 2021, 4:03 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "", "treatment_id": 421, "treatment_name": "Ds-2319b", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|