UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025922 |
|---|---|
| Receipt number | R000029101 |
| Scientific Title | Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial). |
| Date of disclosure of the study information | 2017/02/07 |
| Last modified on | 2017/12/22 09:57:35 |
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Basic information
Public title
Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Acronym
Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Scientific Title
Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Scientific Title:Acronym
Safety and pharmacokinetics of single and repeated dose of intra-nasal TTA-121 in healthy volunteers (Phase 1 trial).
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of single dose (5-200U/ml, 0.1ml/dose) or repeated dose (30-200U/ml, 0.1ml/dose, QD or BID, 9days) intra-nasal TTA-121 in healthy Japanese male volunteers.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
AE
vital signs and body weight
laboratory data
ECG
Key secondary outcomes
plasma concentration of oxytocin
PK parameters of TTA-121
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
<Single dose> TTA-121 (5, 10, 30, 100 or 200U/ml), 0.1mlX1, intra-nasal
<Repeated dose> TTA-121(30, 100 or 200U/ml), 0.1mlx1, QD or BID, 9days
Interventions/Control_2
<Single dose> Placebo, 0.1mlX1, intra-nasal
<Repeated dose> Placebo, 0.1mlx1, QD or BID, 9days
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1) 20~35yrs old, healthy Japanese male
2) Obtained IC
3) BMI 18.5~25 at the time of SCR
4) able to quit smoking from SCR to the follow up date
Key exclusion criteria
1) no history of therapeutic use of oxytocin
2) no history of hypersensitivity of oxytocin
3) no family history of male breast cancer
4) no history or existing condition such as hematological, renal, endocrinological, respiratory, GI tract, cardiovascular, liver, psychological or neurological disease.
5) existing condition which may affect drug absorption, metabolism or secretion.
6) rhinitis or other nasal condition which causes difficulties in intranasal administration.
7) no prior participation and receiving experimental drugs in other clinical trials within 3 months.
8)not suitable to enroll based on medical reasons.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Sakanaka |
Organization
The University of Tokyo Hospital
Division name
Clinical Research Support Center/Phase 1 Unit
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-5800-9513
sakanaka-chie@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mai Harasawa |
Organization
The University of Tokyo Hospital
Division name
Clinical Research Support Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-5800-8743
Homepage URL
mai-harasawa@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
東京大学医学部附属病院臨床研究支援センター P1ユニット
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 07 | 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
| 2017 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029101
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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