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
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
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
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
