臨床研究等提出・公開システム

Date of registration	Dec. 04, 2020
Last modified on	Dec. 04, 2020
Trial ID	jRCT2031200227

Scientific Title	An open-label, randomized, two treatment epochs complete cross-over study to assess pharmacokinetics of indacaterol acetate, glycopyrronium bromide and mometasone furoate in Japanese and Caucasian healthy subjects following multiple inhaled doses of QVM149 via the Concept1 device
Public Title	Pharmacokinetics, safety and tolerability study of QVM149 in Japanese and Caucasian healthy subjects.

Contact for Scientific Queries	Name	Frihata Kenichi
	Affiliation	Keikokai Medical Corp P-one Clinic
	Address	8-1 Yokamachi Hachioji City, Tokyo, 192-0071
	Telephone	+81-42-625-5216
	E-mail	furihata@p1-clinic.or.jp
Contact for Public Queries	Name	Sakita Yohei
	Affiliation	Novartis Pharma K.K.
	Address	23-1, Toranomon 1-chome, MInato-ku, Tokyo 105-6333
	Telephone	+81-70-3191-6913
	E-mail	yohei.sakita@novartis.com

Recruitment status	Complete

Anticipated date of first enrollment		July. 21, 2017
Actual date of first enrollment		July. 21, 2017
Target sample size		33
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male subjects 20 to 45 (inclusive) years of age and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening and first baseline. Japanese subjects are to be of first generation ethnic origin. Caucasian subjects are to be of first generation Caucasian origin.
	Exclusion Criteria	Use of other investigational drugs at screening, or within 5 half-lives of enrollment, or within four (4) months, whichever is longer; or longer if required by local regulations. Inability to use the Concept1 device at screening.
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Athma
Intervention(s)		The study will consist of a screening visit, two treatment epochs, each with a baseline and treatment period, a washout period and an end of study visit. During each treatment epoch, multiple(once daily, 14 days)doses of QVM149 150/50/80 microgram or 150/50/160 microgram by oral inhalation via the Concept1 device.
Primary Outcome(s)		Pharmacokinetics

Primary Sponsor	Novartis Pharma K.K.

Name of Certified Review Board	P-One clinic Institutional Review Board
Address	8-1 Yokamachi Hachioji City, Tokyo, Tokyo
Telephone	+81-42-625-5216
E-Mail	na@xxx.jp
Approval Status	Approval
Date of approval	June. 21, 2017

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none