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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025922
Receipt No. 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

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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
Email 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
Email mai-harasawa@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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