A single-centre, single-dose, open label, non-randomized, parallel group, clinical pharmacology study of CHF 6001 in asthmatic adolescent patients and in asthmatic adult patients as control group

Conditions

Asthma

Brief summary

CHF 6001 Cmax and area under the curve from 0 to the last quantifiable concentration (AUC 0-t).

Detailed description

PK variables will be evaluated after oral inhalation of CHF 6001 3200 μg with NEXThaler® device: • For CHF 6001: apparent systemic clearance (CL/F), time to maximum plasma concentration (tmax), area under the curve from 0 to infinity (AUC0-∞) and elimination half-life (t1/2); • For CHF 5956 and CHF 6095: tmax, AUC0-∞ and apparent terminal t1/2, Cmax and AUC0-t;, PD variables will be evaluated at different times from pre-dose until 10 hours post-dose: • Triplicate 12-lead ECG parameters: HR (including average 0 to 4 hours and 0 to 10 hours) and PR and QRS intervals and QTcF; • Systolic and diastolic BP., Determination of the safety profile will be based on the following assessments at different times from pre-dose until Visit 4 (follow-up visit): • AEs and adverse drug reactions (ADRs); • Standard laboratory parameters (haematology and blood chemistry; at screening and when clinically indicated); • HR from local 12-lead safety ECG (measured during visits); • BP (measured during visits).

Related papers

No related papers found yet.

Interventions

DRUGCHF6001 DPI

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CHF 6001 Cmax and area under the curve from 0 to the last quantifiable concentration (AUC 0-t).	—

Secondary

Measure	Time frame
PK variables will be evaluated after oral inhalation of CHF 6001 3200 μg with NEXThaler® device: • For CHF 6001: apparent systemic clearance (CL/F), time to maximum plasma concentration (tmax), area under the curve from 0 to infinity (AUC0-∞) and elimination half-life (t1/2); • For CHF 5956 and CHF 6095: tmax, AUC0-∞ and apparent terminal t1/2, Cmax and AUC0-t;, PD variables will be evaluated at different times from pre-dose until 10 hours post-dose: • Triplicate 12-lead ECG parameters: HR (including average 0 to 4 hours and 0 to 10 hours) and PR and QRS intervals and QTcF; • Systolic and diastolic BP., Determination of the safety profile will be based on the following assessments at different times from pre-dose until Visit 4 (follow-up visit): • AEs and adverse drug reactions (ADRs); • Standard laboratory parameters (haematology and blood chemistry; at screening and when clinically indicated); • HR from local 12-lead safety ECG (measured during visits); • BP (measured during visits).	—

Measure

Time frame

PK variables will be evaluated after oral inhalation of CHF 6001 3200 μg with NEXThaler® device: • For CHF 6001: apparent systemic clearance (CL/F), time to maximum plasma concentration (tmax), area under the curve from 0 to infinity (AUC0-∞) and elimination half-life (t1/2); • For CHF 5956 and CHF 6095: tmax, AUC0-∞ and apparent terminal t1/2, Cmax and AUC0-t;, PD variables will be evaluated at different times from pre-dose until 10 hours post-dose: • Triplicate 12-lead ECG parameters: HR (including average 0 to 4 hours and 0 to 10 hours) and PR and QRS intervals and QTcF; • Systolic and diastolic BP., Determination of the safety profile will be based on the following assessments at different times from pre-dose until Visit 4 (follow-up visit): • AEs and adverse drug reactions (ADRs); • Standard laboratory parameters (haematology and blood chemistry; at screening and when clinically indicated); • HR from local 12-lead safety ECG (measured during visits); • BP (measured during visits).

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Countries

Bulgaria

Outcome results

None listed