Pharmacokinetics, safety and tolerability study of QVM149 in Japanese and Caucasian healthy subjects.

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200227

Enrollment

Registered

2020-12-04

Start date

2017-07-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athma

Interventions

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 dai

Eligibility

Sex/Gender

Male

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics	—

Contacts

Public ContactYohei Sakita

Novartis Pharma K.K.

yohei.sakita@novartis.com+81-70-3191-6913

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026