Unique ID issued by UMIN | UMIN000031175 |
---|---|
Receipt number | R000035585 |
Scientific Title | A randomised, first-in-human, double-blinded, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CP1050 in healthy subjects; including the effect of food and gender on the pharmacokinetics and pharmacodynamics of a single dose of CP1050 in healthy subjects |
Date of disclosure of the study information | 2018/02/14 |
Last modified on | 2019/09/17 17:20:25 |
A randomised, first-in-human, double-blinded, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CP1050 in healthy subjects; including the effect of food and gender on the pharmacokinetics and pharmacodynamics of a single dose of CP1050 in healthy subjects
A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects
A randomised, first-in-human, double-blinded, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CP1050 in healthy subjects; including the effect of food and gender on the pharmacokinetics and pharmacodynamics of a single dose of CP1050 in healthy subjects
A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects
Europe |
Healthy
Adult |
Others
NO
To investigate the safety and tolerability of single and multiple doses of CP1050 in healthy subjects
PK,PD
Phase I
The primary safety endpoints are as follows:
- incidence and severity of any drug-related adverse events
- vital signs
- clinical laboratory evaluations
- 12-lead safety ECG
- continuous (24-hour) ECG
- pulmonary function test
- ophthalmological assessments
- physical examinations
The PK endpoints include:
- AUClast
- AUCinf
- Cmax
- Tmax
- T1/2
The PD endpoints include absolute peripheral lymphocyte count and percentage change of baseline.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
4
Treatment
Medicine |
CP1050 single oral dose
Placebo single oral dose
CP1050 oral repeated dose for 21 days
Placebo oral repeated dose for 21 days
18 | years-old | <= |
55 | years-old | >= |
Male and Female
- Caucasian males or females between 18 and 55 years of age (inclusive).
- A body weight of >=60 kg for males and >=50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
- Healthy and free from clinically significant illness or disease.
- Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
- Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
- Clinically significant abnormalities in ECG or laboratory tests.
116
1st name | Jim |
Middle name | |
Last name | Bush |
Covance Clinical Research Unit (CRU) Ltd.
Clinical
LS2 9LH
Springfield House, Hyde Street, Leeds, LS2 9LH, United Kingdom
441133013644
Jim.Bush@covance.com
1st name | Tadaki |
Middle name | |
Last name | Sugawara |
Curadim Pharma Co., Ltd.
Development Research Division
100-0004
Otemachi Financial City Grand Cube 3F, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
81342438654
info@curadim.co.jp
Curadim Pharma Co., Ltd.
None
Self funding
North East - York Research Ethics Committee
Jarrow Business Centre, Rolling Mill Road, Jarrow, Tyne & Wear, NE32 3DT United Kingdom
0207 104 8091
nrescommittee.northeast-york@nhs.net
NO
Covance Clinical Research Unit (CRU) Ltd.
2018 | Year | 02 | Month | 14 | Day |
Unpublished
66
Completed
2018 | Year | 01 | Month | 23 | Day |
2018 | Year | 01 | Month | 17 | Day |
2018 | Year | 02 | Month | 05 | Day |
2018 | Year | 12 | Month | 11 | Day |
2018 | Year | 02 | Month | 06 | Day |
2019 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035585
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |