UMIN-ICDS Clinical Trial
| 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 |
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Basic information
Public 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
Acronym
A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects
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
Scientific Title:Acronym
A randomised, first-in-human, double-blinded, placebo-controlled study of CP1050 in healthy subjects
Region
| Europe |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and tolerability of single and multiple doses of CP1050 in healthy subjects
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
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
Key secondary outcomes
The PK endpoints include:
- AUClast
- AUCinf
- Cmax
- Tmax
- T1/2
The PD endpoints include absolute peripheral lymphocyte count and percentage change of baseline.
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CP1050 single oral dose
Interventions/Control_2
Placebo single oral dose
Interventions/Control_3
CP1050 oral repeated dose for 21 days
Interventions/Control_4
Placebo oral repeated dose for 21 days
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- 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.
Key exclusion criteria
- 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.
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Jim |
| Middle name | |
| Last name | Bush |
Organization
Covance Clinical Research Unit (CRU) Ltd.
Division name
Clinical
Zip code
LS2 9LH
Address
Springfield House, Hyde Street, Leeds, LS2 9LH, United Kingdom
TEL
441133013644
Jim.Bush@covance.com
Public contact
Name of contact person
| 1st name | Tadaki |
| Middle name | |
| Last name | Sugawara |
Organization
Curadim Pharma Co., Ltd.
Division name
Development Research Division
Zip code
100-0004
Address
Otemachi Financial City Grand Cube 3F, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL
81342438654
Homepage URL
info@curadim.co.jp
Sponsor or person
Institute
Curadim Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
North East - York Research Ethics Committee
Address
Jarrow Business Centre, Rolling Mill Road, Jarrow, Tyne & Wear, NE32 3DT United Kingdom
Tel
0207 104 8091
nrescommittee.northeast-york@nhs.net
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
Covance Clinical Research Unit (CRU) Ltd.
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 14 | 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
66
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 | 01 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 11 | 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 | 02 | Month | 06 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035585
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