UMIN-CTR Clinical Trial

Public title

A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.

Acronym

Drug interaction study between Midazolam and Anchusan.

Scientific Title

A pilot study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.

Scientific Title:Acronym

Drug interaction study between Midazolam and Anchusan.

Region

Japan

Condition

Japanese healthy male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This is a pilot study to investigate the effects of the 7 days Anchusan multiple dose (7.5g/day) on the pharmacokinetics of oral administration of midazolam (7.5mg) in Japanese healthy male subjects.
The pharmacodynamic interaction between midazolam and Anchusan will also be investigated by using both objective and subjective evaluation.

Basic objectives2

PK,PD

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

The pharmacokinetic parameters of plasma midazolam (AUC(0-10), Cmax, t1/2, tmax)

Key secondary outcomes

1. The sedative action after midazolam oral administration (subjective evaluation: VAS, objective evaluation: simple EEG measurement)
2. Safety assessment (pulse oximeter, vital measurement, adverse event)

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Midazolam single oral administration

Interventions/Control_2

Midazolam single oral administration after 7days Anchusan (7.5g/day) dose

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

45

years-old

>

Gender

Male

Key inclusion criteria

1. Age: 20-45 years old at the time of informed consent
2. Sex: male
3. Subjects are competent to consent, keep the rules of the study and are able to report self condition.
4. Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.

Key exclusion criteria

1. Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements).
2. Any history for drug allergy
3. Subjects who are taking in too much alcohol (those who cannot maintain the abstains from alcohol during study period).
4. Subjects within three months after the participation to other clinical trials
5. Subjects who are inadequate for enrollment judged by the investigator.

Target sample size

3

Name of lead principal investigator

1st name
Middle name
Last name	Naoki Uchida MD, PhD

Organization

Showa University School of Medicine

Division name

Department of Clinical Pharmacology

Zip code

Address

1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555

TEL

03-3784-8128

Email

nuchida@med.showa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Naoki Uchida MD, PhD

Organization

Showa University School of Medicine

Division name

Department of Clinical Pharmacology

Zip code

Address

1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555

TEL

03-3784-8128

Homepage URL

Email

nuchida@med.showa-u.ac.jp

Institute

Showa University School of Medicine Department of Clinical Pharmacology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

昭和大学 臨床薬理研究センター（東京都）
Showa University Clinical Trial Center for Clinical Pharmacology (Tokyo)

Date of disclosure of the study information

2011

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

This pilot study was performed in two subjects. No adverse event was observed during the study in all subjects.
Mean value of PK parameter of plasma Midazolam are as follows;

Pre-dose of Anchu-san
Cmax:112.34 ng/mL, AUC:418.94 ng*hr/mL

After 7 days Anchu-san dose
Cmax:166.85 ng/mL, AUC:528.94 ng*hr/mL

No difference was observed in VAS scale between pre- and post- Anchu-san dose.

It was suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam dose. The verification study will be conducted with increased number of study subjects.

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

2011

Year

10

Month

26

Day

Date of IRB

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

2012

Year

01

Month

01

Day

Date of closure to data entry

2012

Year

06

Month

01

Day

Date trial data considered complete

2012

Year

06

Month

01

Day

Date analysis concluded

2012

Year

06

Month

01

Day

Other related information

Registered date

2011

Year

11

Month

02

Day

Last modified on

2016

Year

04

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007759