UMIN-CTR Clinical Trial

Public title

Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)

Acronym

Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)

Scientific Title

Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)

Scientific Title:Acronym

Pharmacokinetic study of CNT-01 in healthy adults (Phase I study)

Region

Japan

Condition

Idiopathic triglyceride deposit cardiomyovasculopathy

Classification by specialty

Cardiology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess pharmacokinetics and safety of CNT-01 following a single oral dose administration in healthy adults

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Area under the plasma concentration-time curve (AUC0-inf)

Key secondary outcomes

- Maximum plasma concentration (Cmax)
- Time to maximum plasma concentration (tmax)
- Elimination half-life (t1/2)
- Area under the plasma concentration-time curve (AUClast)
- Change in plasma concentration
- Linearity of AUC0-inf vs. dose
- Safety (Adverse events, adverse drug reactions and laboratory tests)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sequential single oral escalating doses of CNT-01(250mg, 500mg and 2000mg) under fasting condition followed by CNT-01 500mg under fed condition

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Gave written informed consent after receiving a sufficient explanation upon participation in the study
2) Between the ages of 20 and 65 at the time of obtaining informed consent
3) Body weight more than 45 kg, height taller than 140 cm and Body Mass Index (BMI) between 17.5 kg/m2 and 30.0 kg/m2 at screening
4) Are able to abstain from smoking throughout the duration of the study
5) Are able to follow the protocol, undergo consultation/examination as described in the protocol and report their symptoms
6) Underwent screening tests within one month before investigational product (IP) administration and judged eligible by the investigator

Key exclusion criteria

1) Have a medically significant complication such as digestive, renal, respiratory, endocrine, hematologic, nervous, psychiatric and cardiovascular disorder and inborn errors of metabolism
2) Had an acute disease within 2 weeks before IP administration (e.g., stomachache, nausea, vomiting, anorexia, fever)
3) Took a prescription drug, over the counter drug, nutrient, vitamin or herbal preparation (including Chinese medicine) within 2 weeks before IP administration
4) Have a present condition or known history of drug or food allergy
5) Participated or are currently participating in another clinical study or post-marketing clinical trial within 3 months before IP administration
6)Ingested any medicine, food or beverage (e.g., coffee, tea, chocolate, coke) containing methylxanthine such as caffeine within 48 hours before IP administration
7)Subjects with or suspected of alcohol or drug abuse at screening
8)Ingested any food or beverage containing grapefruit juice, grapefruit, St. Johns wort or Seville orange within 72 hours before IP administration
9) Fall under any of the following
-received blood transfusion within 3 months before IP administration
-donated whole blood more than or equal to 400 mL within 3 months before IP administration
-donated whole blood more than or equal to 200 mL within a month before IP administration
-donated blood component within 2 weeks before IP administration
10) Had an infection requiring treatment within a month before IP administration
11) Diagnosed with AIDS or HIV positive
12) Positive for HBs antigen, HCV antibody or syphilis serology test
13) Have eGFR less than 60.0 mL/min/1.73 m2 at screening
14) Women who are or may be pregnant, who are unable to practice contraception properly (e.g., avoiding sexual intercourse, using an intrauterine device) within 12 weeks after IP administration or who are lactating
15) Employed by the CRO related to the study or the medical institution
16) Considered unfit for the study by the investigator

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Tomoko Hasunuma

Organization

Oita University Hospital

Division name

Clinical Pharmacology Center

Zip code

Address

1-1 Idaigaoka, Hasama-machi, Yufu city, Oita 879-5593, JAPAN

TEL

+81-97-586-5952

Email

hasunuma@oita-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Naoto Uemura

Organization

Oita University Hospital

Division name

Clinical Pharmacology Center

Zip code

Address

1-1 Idaigaoka, Hasama-machi, Yufu city, Oita 879-5593, JAPAN

TEL

+81-97-586-5952

Homepage URL

Email

uemura@oita-u.ac.jp

Institute

Oita University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Osaka University Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大分大学医学部附属病院　　　　　　　　　　　　　　　　　　　　　　Oita University Hospital

Date of disclosure of the study information

2016

Year

05

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

04

Month

28

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

02

Day

Last modified on

2016

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025419