臨床研究等提出・公開システム

Date of registration	July. 01, 2021
Last modified on	Aug. 31, 2022
Trial ID	jRCT1030210178

Scientific Title	Study to Evaluate the Safety, Tolerability, and plasma hydroxyproline concentration of load of gelatin in the Healthy Adult Subjects
Public Title	Study to Evaluate the Safety, Tolerability, and plasma hydroxyproline concentration of load of gelatin in the Healthy Adult Subjects

Completion date	Oct. 03, 2021
Result actual enrolment	12
Baseline Characteristics	The study consisted of two parts, part 1 and part 2. The mean age in part 1 (6 patients) was 28.7 (4.3) years (mean [SD]; hereafter the same), and the mean BMI was 20.95 (1.14) kg/m2. The mean age in part 2 (6 patients) was 32.5 (8.7) years and the mean BMI was 21.30 (1.83) kg/m2.
Participant flow	Of the 39 subjects who gave informed consent, 6 participated in part 1 and 6 participated in part 2; a total of 12 subjects received oral gelatin loading. All subjects completed the study, and there were no withdrawals after gelatin loading.
Adverse events	No adverse event was reported in either part 1 or part 2.
Outcome measures	Cmax and AUC0-t of plasma hydroxyproline increased in proportion to gelatine loading dose, and tmax and t1/2 did not vary significantly due to differences in the gelatin loading dose. No adverse events and no significant changes in laboratory values or vital signs was reported.
Brief summary	Oral loading of healthy adult men with gelatin resulted in a proportional increase in plasma hydroxyproline concentration with gelatin loading dose. The safety and tolerability of oral gelatine loading was clinically acceptable.
Date of posting of results summaries	Aug. 31, 2022

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1030210178

Contact for Scientific Queries	Name	Furihata Kenichi
	Affiliation	P-One Clinic, Keikokai Medical Corporation
	Address	View Tower Hachioji 4F, 8-1, Yokamachi, Hachioji City, Tokyo
	Telephone	+81-42-625-5216
	E-mail	furihata@p1-clinic.or.jp
Contact for Public Queries	Name	Takeuchi Yutaka
	Affiliation	EA Pharma Co., Ltd.
	Address	2-1-1, Irifune, Chuo-ku, Tokyo
	Telephone	+81-3-6280-9600
	E-mail	contact_ea@eapharma.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 29, 2021
Actual date of first enrollment		June. 29, 2021
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Male BMI: 18.5 kg/m2 or more, less than 25.0 kg/m2
	Exclusion Criteria	Presence of a psychological, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, immune, neurological, cardiovascular disease or a congenital metabolic abnormality or other anomaly that may affect this study
	Age Minimum	20age old over
	Age Maximum	44age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy Adult Subjects
Intervention(s)		Ingestion of gelatin
Primary Outcome(s)		Plasma hydroxyproline concentration Safety endpoints (Adverse events, Laboratory tests, Vital signs)
Secondary Outcome(s)		none

Primary Sponsor	EA Pharma co., Ltd.

Secondary Sponsor

Source of Monetary Support	EA Pharma co., Ltd.
Secondary Sponsor	Applicable

Name of Certified Review Board	P-One Clinic, Keikokai Medical Corporation. Ethics Review Board
Address	View Tower Hachioji 4F, 8-1, Yokamachi, Hachioji City, Tokyo
Telephone	+81-42-625-5216
E-Mail	irbjimukyoku@p1-clinic.or.jp
Approval Status	Approval
Date of approval	June. 28, 2021

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Aug. 31, 2022	(this page)	Changes
3	Dec. 20, 2021	Detail	Changes
2	July. 15, 2021	Detail	Changes
1	July. 01, 2021	Detail

List of change history