Trial Outcomes & Findings for Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects (NCT NCT04756960)

Results Overview

AUC(0-t\_iv) for \[14\^C\] total in plasma. AUC(0-t\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Results posted on

2024-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	CHF6001 Single dose of CHF6001 dry-powder inhaler (DPI) co-administered with an intravenous microdose of \[14\^C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14\^C\]-labelled CHF6001
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14\^C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14\^C\]-labelled CHF6001
Age, Continuous	36.3 years STANDARD_DEVIATION 4.4 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United Kingdom	8 participants n=93 Participants
Body mass index	28.09 kg/m^2 STANDARD_DEVIATION 4.73 • n=93 Participants

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

AUC(0-t\_iv) for \[14\^C\] total in plasma. AUC(0-t\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- AUC(0-t_iv) -- Plasma -- [14^C] Total	5.4025 h*ngEq/mL Geometric Coefficient of Variation 16.7

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

C(max\_iv) for \[14\^C\] total in plasma. C(max\_iv)=Peak plasma concentration after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- C(max_iv) -- Plasma -- [14^C] Total	0.7072 ngEq/mL Geometric Coefficient of Variation 21.6

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

t(max\_iv) for \[14\^C\] total. t(max\_iv)=Time to reach the Cmax, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- t(max_iv) -- Plasma -- [14^C] Total	0.217 h Interval 0.17 to 0.25

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Area under curve extrapolated to infinity (AUC(0-∞\_iv) for \[14\^C\] total in plasma. AUC(0-∞\_iv)=Area under curve extrapolated to infinity, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=6 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- AUC(0-∞_iv) -- Plasma -- [14^C] Total	6.0825 h*ngEq/mL Geometric Coefficient of Variation 19.6

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Terminal half-life t(1/2\_iv) for \[14\^C\] total and CHF6001. t1/2\_iv=Terminal half-life, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=6 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- t(1/2_iv) -- Plasma -- [14^C] Total	72.4057 h Interval 56.446 to 105.776

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at 20 min after the start of IV infusion.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Blood to plasma ratio for \[14\^C\] total.

Outcome measures

Outcome measures
Measure	CHF6001 n=6 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- (Blood to Plasma Ratio) -- Blood, Plasma -- [14^C] Total	0.6490 Ratio Geometric Coefficient of Variation 23.9

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

AUC(0-t\_iv) for \[14\^C\] CHF6001 in plasma. AUC(0-t\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- AUC(0-t_iv) -- Plasma -- [14^C] CHF6001	0.7825 h*ng/mL Geometric Coefficient of Variation 18.2

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

C(max\_iv) for \[14\^C\] CHF6001 in plasma. C(max\_iv)=Peak plasma concentration, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- C(max_iv) -- Plasma -- [14^C] CHF6001	0.6312 ng/mL Geometric Coefficient of Variation 19.1

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

t(max\_iv) for \[14\^C\] CHF6001. t(max\_iv)=Time to reach the Cmax, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- t(max_iv) -- Plasma -- [14^C] CHF6001	0.217 h Interval 0.17 to 0.25

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Area under curve extrapolated to infinity (AUC0-∞\_iv) for \[14\^C\] CHF6001 in plasma. AUC(0-∞\_iv)=Area under curve extrapolated to infinity, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- AUC(0-∞_iv) -- Plasma -- [14^C] CHF6001	0.8138 h*ng/mL Geometric Coefficient of Variation 18.6

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Terminal half-life t(1/2\_iv) for \[14\^C\] CHF6001 in plasma. t(1/2\_iv)=Terminal half-life, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- t(1/2_iv) -- Plasma -- [14^C] CHF6001	13.5816 h Interval 6.452 to 33.092

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Volume of distribution during the terminal phase (Vz\_iv) of \[14\^C\] CHF6001 in plasma. Vz\_iv=Volume of distribution during the terminal phase, after intravenous (iv) infusion administration

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Volume of Distribution During the Terminal Phase (Vz_iv) -- Plasma -- [14^C] CHF6001	436.1078 Litres Geometric Coefficient of Variation 38.6

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Vdss\_iv=Volume of distribution is calculated at steady-state for \[14\^C\] CHF6001 in plasma, after intravenous (iv) infusion administration.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Vdss_iv -- Plasma -- [14^C] CHF6001	201.2514 Litres Geometric Coefficient of Variation 36.2

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Systemic plasma clearance for \[14\^C\] CHF6001.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Clearance (CL_iv) -- Plasma -- [14^C] CHF6001	21.9951 Litres/h Geometric Coefficient of Variation 18.6

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at 20 min after the start of IV infusion.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Blood to plasma ratio for \[14\^C\] CHF6001.

Outcome measures

Outcome measures
Measure	CHF6001 n=6 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Blood to Plasma Ratio -- Blood, Plasma -- [14^C] CHF6001	0.5166 Ratio Geometric Coefficient of Variation 54.9

PRIMARY outcome

Timeframe: At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

AUC(0-t)\_inh for CHF6001 in plasma. AUC(0-t)\_inh=Area Under the curve, from 0 to the last quantifiable concentration after inhalation of CHF6001

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- AUC(0-t)_inh -- Plasma -- CHF6001	71088 h*pg/mL Standard Deviation 28.2

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

C(max\_inh) for CHF6001 in plasma. C(max\_inh)=Peak plasma concentration after inhalation of CHF6001

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- C(max_inh) -- Plasma -- CHF6001	1979 pg/mL Geometric Coefficient of Variation 22.5

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

t(max\_inh) for CHF6001 in plasma. t(max\_inh)=Time to reach the Cmax after inhalation of CHF6001

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- t(max_inh) -- Plasma -- CHF6001	2.008 h Interval 2.0 to 3.75

PRIMARY outcome

Timeframe: At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

AUC(0-∞\_inh) for CHF6001 in plasma. AUC(0-∞\_inh)=Area under curve extrapolated to infinity after inhalation of CHF6001

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- AUC(0-∞_inh) -- Plasma -- CHF6001	72403 h*pg/mL Geometric Coefficient of Variation 28.4

PRIMARY outcome

Timeframe: Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

t(1/2\_inh) for CHF6001 in plasma. t(1/2\_inh)=Terminal half-life, after inhalation of CHF6001

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- t(1/2_inh) -- Plasma -- CHF6001	41.5691 h Interval 25.93 to 45.159

PRIMARY outcome

Timeframe: At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Absolute inhaled bioavailability for CHF6001. F\_inh=Inhaled absolute bioavailability based on AUC(0-∞) after inhalation of CHF6001 F\_inh=(AUC(0-∞)\_inh x Dose\_iv)/ (AUC(0-∞)\_iv x Dose\_inh).

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Absolute Inhaled Bioavailability (F_inh) -- Plasma -- CHF6001	0.4977 Ratio Geometric Coefficient of Variation 26.8

PRIMARY outcome

Timeframe: Baseline (pre dose, -12-0h) and relative to the start of the IV infusion at: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216-240h.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Urine excreted fraction for cumulative \[14\^C\] total.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 0-4 h	1.99 Cumulative % of dose excreted in urine Standard Deviation 0.523
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 4-8 h	3.26 Cumulative % of dose excreted in urine Standard Deviation 0.552
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 8-12 h	3.93 Cumulative % of dose excreted in urine Standard Deviation 0.549
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 12-24 h	5.24 Cumulative % of dose excreted in urine Standard Deviation 0.554
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 24-48 h	6.77 Cumulative % of dose excreted in urine Standard Deviation 0.519
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 48-72 h	7.35 Cumulative % of dose excreted in urine Standard Deviation 0.553
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 72-96 h	7.64 Cumulative % of dose excreted in urine Standard Deviation 0.622
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 96-120 h	7.80 Cumulative % of dose excreted in urine Standard Deviation 0.673
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 120-144 h	7.89 Cumulative % of dose excreted in urine Standard Deviation 0.703
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 144-168 h	7.96 Cumulative % of dose excreted in urine Standard Deviation 0.720
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 168-192 h	8.01 Cumulative % of dose excreted in urine Standard Deviation 0.729
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 192-216 h	8.06 Cumulative % of dose excreted in urine Standard Deviation 0.763
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total 216-240 h	8.10 Cumulative % of dose excreted in urine Standard Deviation 0.771

PRIMARY outcome

Timeframe: Baseline (pre dose, -12-0h) and relative to the start of the IV infusion at: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216-240h.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications. Measurements in urine were performed and no substance was detected.

Urine excreted fraction for cumulative \[14\^C\]-CHF6001. Measurements in urine were performed. All measured values were below the limit of quantification of the bioanalytical method.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-4 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-8 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-12 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-24 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-48 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-72 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-96 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-120 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-144 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-168 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-192 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-216 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001 0-240 h	0.00 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline (pre dose, Day -1) and relative to the start of the IV infusion at: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216 -240h.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Fecal excreted fraction for cumulative \[14\^C\] total.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 0-24 h	7.64 Cumulative % of dose excreted in feces Standard Deviation 12.0
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 24-48 h	38.9 Cumulative % of dose excreted in feces Standard Deviation 20.6
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 48-72 h	57.7 Cumulative % of dose excreted in feces Standard Deviation 8.53
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 72-96 h	64.9 Cumulative % of dose excreted in feces Standard Deviation 4.26
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 96-120 h	68.6 Cumulative % of dose excreted in feces Standard Deviation 2.35
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 120-144 h	69.6 Cumulative % of dose excreted in feces Standard Deviation 2.08
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 144-168 h	70.0 Cumulative % of dose excreted in feces Standard Deviation 2.09
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 168-192 h	70.5 Cumulative % of dose excreted in feces Standard Deviation 2.19
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 192-216 h	70.7 Cumulative % of dose excreted in feces Standard Deviation 2.22
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total 216-240 h	70.8 Cumulative % of dose excreted in feces Standard Deviation 2.26

PRIMARY outcome

Timeframe: Baseline (pre dose, Day -1) and relative to the start of the IV infusion at: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216 -240h.

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Fecal excreted fraction for cumulative \[14\^C\]-CHF6001.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-24 h	0.0435 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0676
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-48 h	0.1748 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0895
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-72 h	0.2507 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0855
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-96 h	0.2816 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0685
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-120 h	0.3048 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0660
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-144 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-168 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-192 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-216 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001 0-240 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642

PRIMARY outcome

Timeframe: Over 240 h after administration; please see timepoints for outcome #22 (urine) and #24 (fecal).

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Urine and fecal excreted fraction for cumulative \[14\^C\] total.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 0-4 h	1.99 Cumulative % of dose excreted Standard Deviation 0.523
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 4-8 h	3.26 Cumulative % of dose excreted Standard Deviation 0.552
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 8-12 h	3.93 Cumulative % of dose excreted Standard Deviation 0.549
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 12-24 h	12.9 Cumulative % of dose excreted Standard Deviation 12.3
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 24-48 h	45.6 Cumulative % of dose excreted Standard Deviation 20.8
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 48-72 h	65.1 Cumulative % of dose excreted Standard Deviation 8.67
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 72-96 h	72.5 Cumulative % of dose excreted Standard Deviation 4.12
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 96-120 h	76.4 Cumulative % of dose excreted Standard Deviation 2.46
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 120-144 h	77.5 Cumulative % of dose excreted Standard Deviation 2.23
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 144-168 h	77.9 Cumulative % of dose excreted Standard Deviation 2.32
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 168-192 h	78.5 Cumulative % of dose excreted Standard Deviation 2.46
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 192-216 h	78.7 Cumulative % of dose excreted Standard Deviation 2.51
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total 216-240 h	78.9 Cumulative % of dose excreted Standard Deviation 2.58

PRIMARY outcome

Timeframe: Over 240 h after administration; please see timepoints for outcome #22 (urine) and #24 (fecal).

Population: Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.

Urine and Fecal excreted fraction for cumulative \[14\^C\]-CHF6001.

Outcome measures

Outcome measures
Measure	CHF6001 n=8 Participants Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-216 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-240 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-24 h	0.0435 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0676
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-48 h	0.1748 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0895
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-72 h	0.2507 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0855
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-96 h	0.2816 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0685
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-120 h	0.3048 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0660
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-144 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-168 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642
PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001 0-192 h	0.3060 (%) percent of injected [14C]-CHF6001 Standard Deviation 0.0642

Adverse Events

CHF6001

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CHF6001 n=8 participants at risk Single dose of CHF6001 DPI co-administered with an intravenous microdose of \[14C\]-labelled CHF6001 CHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \[14C\]-labelled CHF6001
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • Adverse events were monitored from the time of the Informed Consent signature (screening visit at 31 to 3 days before the study treatment administration) until the subject's study participation ended (follow-up phone call or visit at 7 to 10 days after discharge or premature discontinuation).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Number of events 1 • Adverse events were monitored from the time of the Informed Consent signature (screening visit at 31 to 3 days before the study treatment administration) until the subject's study participation ended (follow-up phone call or visit at 7 to 10 days after discharge or premature discontinuation).
Gastrointestinal disorders Abdominal pain lower	12.5% 1/8 • Number of events 1 • Adverse events were monitored from the time of the Informed Consent signature (screening visit at 31 to 3 days before the study treatment administration) until the subject's study participation ended (follow-up phone call or visit at 7 to 10 days after discharge or premature discontinuation).

Additional Information

Clinical Trial Transparency

Chiesi Farmaceutici S.p.A.

Phone: + 39 0521 2791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator should inform Chiesi Farmaceutici S.p.A. before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation.
Publication restrictions are in place

Restriction type: OTHER