UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005923
Receipt number R000007006
Scientific Title Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen
Date of disclosure of the study information 2011/08/22
Last modified on 2011/11/01 10:54:01

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Basic information

Public title

Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen

Acronym

Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen

Scientific Title

Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen

Scientific Title:Acronym

Phase 1 comparative study of intravenous formulation of acetaminophen and oral formulation of acetaminophen

Region

Japan


Condition

Condition

Healthy male subjects

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Infectious disease Geriatrics
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obstetrics and Gynecology Pediatrics
Oto-rhino-laryngology Orthopedics Urology
Radiology Anesthesiology Oral surgery
Neurosurgery Cardiovascular surgery Plastic surgery
Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the pharmacokinetics, safety and tolerability of TRM-1106 and oral formulation of acetaminophen in healthy Japanese adult men

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pharmacokinetics of TRM-1106

Key secondary outcomes

Safety


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The A group will receive TRM-1106 100 mL in Period 1 and Oral formulation of acetaminophen 1000 mg in Period 2.
A 6-day washout period will be given between the administration periods.

Interventions/Control_2

The B group will receive Oral formulation of acetaminophen 1000 mg in Period 1 and TRM-1106 100 mL in Period 2.
A 6-day washout period will be given between the administration periods.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1) Male subject aged at least 20 years (at the date of signing the consent form)
2) Subject who has voluntarily provided written consent prior to enrollment, and is willing to continuously participate in the Study.
3) Subject with a body weight of >=50.0 kg, and a body mass index (BMI) between 18.0 and 35.0. However, subject may participate even if outside this range. In such a case, the investigator or sub-investigator must determine whether it is medically tolerable.
4) Subject without any medically significant abnormality in clinical symptoms or signs (in the results of medical examinations, laboratory tests, and physiological tests)
5) Subject who can take effective contraceptive measures during the study period.

Key exclusion criteria

1) Subject who has been tested positive in a urine drug test or has a history of drug abuse.
2) Subject who has been tested positive for HBs antigen, HCV antibody or HIV antibody, or who has a positive serological test for syphilis.
3) Subject who has a history of hypersensitivity or allergy to the study drug (active component and additives)
4) Subject who currently has or has a history of peptic ulcer; or subject who currently has or has a history of asthma.
5) Subject with clinically significant disease related to the heart, liver, kidneys, respiratory system, gastrointestinal system, endocrine system, immune system, skin, blood, or psychiatric/nervous system.
6) Subject who has liver function test values (T-Bil/D-Bil, ALT (GPT), AST (GOT), gamma-GTP and ALP) that exceed the facility's upper limit. However, if the investigator deems that the reason for exceeding the limit is not due to the liver, the subject may be enrolled.
7) Subject who currently has or have a history of clinically significant bleeding or bleeding tendency.
8) Subject who has taken other medication or supplements within 1 week prior to study drug administration.
9) Subject who need to take other medication concurrently while participating in this study.
10) Subject who smoked tobacco within 1 month prior to study drug administration.
11) Subject who habitually consume a large amount of alcohol (ingestion of >=60 g per day as pure alcohol), or have ingested alcohol within 3 days prior to study drug administration.
12) Subject who has ingested food products containing St. John's wort within 2 weeks prior to study drug administration.
13) Subjects who has ingested grapefruit or processed grapefruit products within 1 week prior to study drug administration.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nakatani

Organization

Hosen Clinic, Research Center for Clinical Pharmacology, Kitasato University

Division name

Internal medicine

Zip code


Address

1-28-16 Komagome, Toshima-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Yamamoto

Organization

Terumo Corporation

Division name

Clinical Development Department

Zip code


Address

1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Terumo Corporation

Institute

Department

Personal name



Funding Source

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 22 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


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

2011 Year 05 Month 26 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 07 Month 05 Day

Last modified on

2011 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name