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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031175
Receipt No. R000035585
Official scientific title of the study 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 2018/02/14

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Basic information
Official scientific title of the study 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
Title of the study (Brief title) 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 Dr. Jim Bush, MBChB, PhD, MRCS, FFPM
Organization Covance Clinical Research Unit (CRU) Ltd.
Division name Clinical
Address Springfield House, Hyde Street, Leeds, LS2 9LH, United Kingdom
TEL 441133013644
Email Jim.Bush@covance.com

Public contact
Name of contact person Dr. Tadaki Sugawara, PhD.
Organization Curadim Pharma Co., Ltd.
Division name Development Research Division
Address Otemachi Financial City Grand Cube 3F, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL 81342438654
Homepage URL
Email info@curadim.co.jp

Sponsor
Institute Curadim Pharma Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 23 Day
Anticipated trial start date
2018 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 02 Month 06 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.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


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