Trial Outcomes & Findings for A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib (NCT NCT03398421)

Results Overview

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic parameters of nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic population comprised of all participants enrolled in the study who took at least 1 dose of nemiralisib and for whom a nemiralisib pharmacokinetic sample was obtained and analyzed.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5

Results posted on

2020-04-27

Participant Flow

This was a Phase I, single center, open label, one sequence cross-over study conducted in healthy males and females of non-child bearing potential to evaluate the pharmacokinetic (PK), safety and tolerability of nemiralisib administered alone and concomitantly with repeated doses of itraconazole.

A total of 20 participants were enrolled at a single center in the United States.

Participant milestones

Participant milestones
Measure	Nemiralisib 100 mcg Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 Milligram(mg) With 100mcg Nemiralisib After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Treatment Period 1 (Up to 6 Days) STARTED	20	0
Treatment Period 1 (Up to 6 Days) COMPLETED	20	0
Treatment Period 1 (Up to 6 Days) NOT COMPLETED	0	0
Washout Period (Up to 14 Days) STARTED	20	0
Washout Period (Up to 14 Days) COMPLETED	20	0
Washout Period (Up to 14 Days) NOT COMPLETED	0	0
Treatment Period 2 (Up to 11 Days) STARTED	0	20
Treatment Period 2 (Up to 11 Days) COMPLETED	0	20
Treatment Period 2 (Up to 11 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=20 Participants Participants received a single 100 mcg inhaled oral dose of Nemiralisib on Day 1 in Period 1, followed by a washout period of 14 days. In treatment period 2, participants received an oral dose of 200 mg itraconazole from Days 1 to 10 and on Day 5 a single inhaled oral dose of 100 mcg nemiralisib was administered one hour after itraconazole dosing.
Age, Continuous	36.1 Years STANDARD_DEVIATION 12.37 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Count of Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Count of Participants n=5 Participants
Race/Ethnicity, Customized White/ Caucasian/ European Heritage	14 Count of Participants n=5 Participants

PRIMARY outcome

Timeframe: Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic parameters of nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic population comprised of all participants enrolled in the study who took at least 1 dose of nemiralisib and for whom a nemiralisib pharmacokinetic sample was obtained and analyzed.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of Nemiralisib in Plasma Day 1, n=20, 0	3199.0 Hours*picogram per milliliter Geometric Coefficient of Variation 29.8	—
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of Nemiralisib in Plasma Day 5, n=0, 14	—	6272.7 Hours*picogram per milliliter Geometric Coefficient of Variation 27.5

PRIMARY outcome

Timeframe: Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate pharmacokinetic parameters of Nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Nemiralisib in Plasma Day 1; n=20, 0	2677.1 Hour*picogram per milliliter Geometric Coefficient of Variation 30.2	—
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Nemiralisib in Plasma Day 5; n=0, 20	—	4802.3 Hour*picogram per milliliter Geometric Coefficient of Variation 29.1

PRIMARY outcome

Timeframe: Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate pharmacokinetic parameters of Nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Maximum Observed Plasma Concentration (Cmax) of Nemiralisib in Plasma Day 1; n=20, 0	478.7 Picogram per milliliter Geometric Coefficient of Variation 41.9	—
Maximum Observed Plasma Concentration (Cmax) of Nemiralisib in Plasma Day 5; n=0, 20	—	384.0 Picogram per milliliter Geometric Coefficient of Variation 34.0

PRIMARY outcome

Timeframe: Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate pharmacokinetic parameters of Nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Apparent Terminal Half-life (t1/2) of Nemiralisib in Plasma Day 1, n=20, 0	40.03 Hours Geometric Coefficient of Variation 21.7	—
Apparent Terminal Half-life (t1/2) of Nemiralisib in Plasma Day 5, n=0, 14	—	64.00 Hours Geometric Coefficient of Variation 11.4

PRIMARY outcome

Timeframe: Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Blood samples were collected at indicated time points after administration of repeated doses of itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Time to Maximum Observed Plasma Concentration (Tmax) of Nemiralisib in Plasma Day 5; n=0, 20	—	0.088 Hour Interval 0.08 to 0.1
Time to Maximum Observed Plasma Concentration (Tmax) of Nemiralisib in Plasma Day 1; n=20, 0	0.070 Hour Interval 0.07 to 0.08	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed. NA indicates AUC (0-inf) for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.

Blood samples were collected at indicated time points after administration of repeated doses of itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
AUC(0-inf) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 1	1201.3 Hour*nanogram per milliliter Geometric Coefficient of Variation 46.3	—
AUC(0-inf) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 5	NA Hour*nanogram per milliliter Geometric Coefficient of Variation NA NA indicates AUC (0-inf) for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.	—
AUC(0-inf) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 1	NA Hour*nanogram per milliliter Geometric Coefficient of Variation NA NA indicates AUC (0-inf) for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.	—
AUC(0-inf) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 5	NA Hour*nanogram per milliliter Geometric Coefficient of Variation NA NA indicates AUC (0-inf) for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5

Population: Pharmacokinetic population.

Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
AUC(0-t) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 1	891.7 Hour*nanogram per milliliter Geometric Coefficient of Variation 60.0	—
AUC(0-t) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 5	4939.6 Hour*nanogram per milliliter Geometric Coefficient of Variation 60.2	—
AUC(0-t) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 1	1862.6 Hour*nanogram per milliliter Geometric Coefficient of Variation 48.8	—
AUC(0-t) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 5	10106.4 Hour*nanogram per milliliter Geometric Coefficient of Variation 50.3	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5

Population: Pharmacokinetic population.

Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole and Hydroxy Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Cmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 1	156.90 Nanogram per milliliter Geometric Coefficient of Variation 59.0	—
Cmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 5	472.52 Nanogram per milliliter Geometric Coefficient of Variation 63.7	—
Cmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 1	240.3 Nanogram per milliliter Geometric Coefficient of Variation 45.2	—
Cmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 5	541.2 Nanogram per milliliter Geometric Coefficient of Variation 41.8	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5

Population: Pharmacokinetic population. Only those participants with data available at specified time points were analyzed. NA indicates T1/2 for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.

Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole and Hydroxy Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=7 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
T1/2 of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 1	3.865 Hour Geometric Coefficient of Variation 7.7	—
T1/2 of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 5	NA Hour Geometric Coefficient of Variation NA NA indicates T1/2 for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.	—
T1/2 of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 1	NA Hour Geometric Coefficient of Variation NA NA indicates T1/2 for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.	—
T1/2 of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 5	NA Hour Geometric Coefficient of Variation NA NA indicates T1/2 for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5

Population: Pharmacokinetic population.

Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole and Hydroxy Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Tmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 1	4.001 Hour Interval 2.0 to 6.0	—
Tmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Itraconazole, Day 5	4.001 Hour Interval 2.0 to 6.0	—
Tmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 1	4.004 Hour Interval 3.0 to 6.01	—
Tmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2 Hydroxy Itraconazole, Day 5	4.004 Hour Interval 3.0 to 8.01	—

SECONDARY outcome

Timeframe: Up to 35 days

Population: Safety population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Any AE	1 Participants	4 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Any SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1) and Day 6

Population: Safety population.

Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Calcium, Glucose, Potassium and Sodium Glucose	-0.12 Millimoles/Liter Standard Deviation 0.247	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Calcium, Glucose, Potassium and Sodium Calcium	0.06 Millimoles/Liter Standard Deviation 0.070	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Calcium, Glucose, Potassium and Sodium Potassium	0.20 Millimoles/Liter Standard Deviation 0.290	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Calcium, Glucose, Potassium and Sodium Sodium	-0.9 Millimoles/Liter Standard Deviation 2.05	—

SECONDARY outcome

Timeframe: Baseline (Day -1), Day 2, 4, 6, 8 and 10

Population: Safety population.

Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Glucose, Day 2	-0.08 Millimoles/Liter Standard Deviation 0.256	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Glucose, Day 4	-0.12 Millimoles/Liter Standard Deviation 0.291	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Glucose, Day 6	1.22 Millimoles/Liter Standard Deviation 1.055	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Glucose, Day 8	-0.22 Millimoles/Liter Standard Deviation 0.346	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Glucose, Day 10	-0.22 Millimoles/Liter Standard Deviation 0.280	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Calcium, Day 2	0.02 Millimoles/Liter Standard Deviation 0.066	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Calcium, Day 4	0.03 Millimoles/Liter Standard Deviation 0.069	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Calcium, Day 6	0.05 Millimoles/Liter Standard Deviation 0.081	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Calcium, Day 8	0.00 Millimoles/Liter Standard Deviation 0.077	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Calcium, Day 10	0.03 Millimoles/Liter Standard Deviation 0.059	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Potassium, Day 2	0.07 Millimoles/Liter Standard Deviation 0.326	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Potassium, Day 4	0.29 Millimoles/Liter Standard Deviation 0.381	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Potassium, Day 6	0.01 Millimoles/Liter Standard Deviation 0.348	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Potassium, Day 8	0.21 Millimoles/Liter Standard Deviation 0.323	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Potassium, Day 10	0.20 Millimoles/Liter Standard Deviation 0.339	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Sodium, Day 2	-1.0 Millimoles/Liter Standard Deviation 1.59	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Sodium, Day 4	0.0 Millimoles/Liter Standard Deviation 2.55	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Sodium, Day 6	-1.6 Millimoles/Liter Standard Deviation 1.73	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Sodium, Day 8	-1.0 Millimoles/Liter Standard Deviation 1.72	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium Sodium, Day 10	-1.6 Millimoles/Liter Standard Deviation 2.09	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphate, ALT and AST at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Alkaline Phosphate, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Alkaline phosphate	0.8 International Units/ Liter Standard Deviation 8.08	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Alkaline Phosphate, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ALT	1.5 International Units/ Liter Standard Deviation 7.40	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Alkaline Phosphate, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) AST	-0.5 International Units/ Liter Standard Deviation 3.40	—

SECONDARY outcome

Timeframe: Baseline, Day 2, 4, 6, 8 and 10

Population: Safety population.

Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphate, ALT and AST at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST Alkaline phosphate, Day 2	-7.0 International Units/ Liter Standard Deviation 6.99	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST Alkaline phosphate, Day 4	-8.5 International Units/ Liter Standard Deviation 7.00	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST Alkaline phosphate, Day 6	-7.2 International Units/ Liter Standard Deviation 9.09	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST Alkaline phosphate, Day 8	-7.6 International Units/ Liter Standard Deviation 8.02	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST Alkaline phosphate, Day 10	-5.3 International Units/ Liter Standard Deviation 9.35	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST ALT, Day 2	-3.2 International Units/ Liter Standard Deviation 4.46	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST ALT, Day 4	-3.2 International Units/ Liter Standard Deviation 3.82	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST ALT, Day 6	-2.9 International Units/ Liter Standard Deviation 3.11	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST ALT, Day 8	-2.6 International Units/ Liter Standard Deviation 2.96	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST ALT, Day 10	-2.8 International Units/ Liter Standard Deviation 4.79	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST AST, Day 2	-2.6 International Units/ Liter Standard Deviation 3.82	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST AST, Day 4	-3.0 International Units/ Liter Standard Deviation 3.18	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST AST, Day 6	-2.4 International Units/ Liter Standard Deviation 2.96	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST AST, Day 8	-3.2 International Units/ Liter Standard Deviation 2.91	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST AST, Day 10	-2.0 International Units/ Liter Standard Deviation 3.87	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, direct bilirubin and creatinine at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered:Bilirubin, Direct Bilirubin and Creatinine Bilirubin	5.557 Micromoles per liter Standard Deviation 7.2310	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered:Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin	2.394 Micromoles per liter Standard Deviation 0.8595	—
Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered:Bilirubin, Direct Bilirubin and Creatinine Creatinine	-3.094 Micromoles per liter Standard Deviation 6.5872	—

SECONDARY outcome

Timeframe: Baseline, Day 2, 4, 6, 8 and 10

Population: Safety population.

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, direct bilirubin and creatinine at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Day 2	0.428 Micromoles per liter Standard Deviation 2.7670	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Day 4	1.796 Micromoles per liter Standard Deviation 2.5710	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Day 6	2.907 Micromoles per liter Standard Deviation 2.9928	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Day 8	2.309 Micromoles per liter Standard Deviation 2.6766	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Day 10	3.506 Micromoles per liter Standard Deviation 2.7447	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Day 2	2.907 Micromoles per liter Standard Deviation 0.9768	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Day 4	2.394 Micromoles per liter Standard Deviation 1.0230	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Day 6	1.796 Micromoles per liter Standard Deviation 0.8728	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Day 8	2.052 Micromoles per liter Standard Deviation 0.7018	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Day 10	2.907 Micromoles per liter Standard Deviation 1.3702	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Day 2	0.442 Micromoles per liter Standard Deviation 8.8284	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Day 4	2.210 Micromoles per liter Standard Deviation 7.5202	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Day 6	0.884 Micromoles per liter Standard Deviation 7.5338	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Day 8	0.442 Micromoles per liter Standard Deviation 7.8414	—
Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Day 10	0.000 Micromoles per liter Standard Deviation 8.6042	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of total protein at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Total Protein When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered	3.3 Gram per liter Standard Deviation 3.85	—

SECONDARY outcome

Timeframe: Baseline, Day 2, 4, 6, 8 and 10

Population: Safety population.

Blood samples were collected for the analysis of total protein at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline of Total Protein When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose Day 2	-3.8 Gram per liter Standard Deviation 3.52	—
Change From Baseline of Total Protein When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose Day 4	-3.4 Gram per liter Standard Deviation 3.03	—
Change From Baseline of Total Protein When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose Day 6	0.2 Gram per liter Standard Deviation 3.74	—
Change From Baseline of Total Protein When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose Day 8	-2.4 Gram per liter Standard Deviation 3.86	—
Change From Baseline of Total Protein When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose Day 10	-1.8 Gram per liter Standard Deviation 2.95	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of hematology parameters including lymphocytes, neutrophils, platelets, basophils, eosinophils, monocytes, erythrocytes and WBCs at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Lymphocytes	-0.264 10^9 cells per liter Standard Deviation 0.579	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Neutrophils	0.198 10^9 cells per liter Standard Deviation 0.736	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Platelets	8.4 10^9 cells per liter Standard Deviation 31.74	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Basophils	0.003 10^9 cells per liter Standard Deviation 0.014	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Eosinophils	-0.038 10^9 cells per liter Standard Deviation 0.047	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Monocytes	-0.054 10^9 cells per liter Standard Deviation 0.108	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) Erythrocytes	242.0 10^9 cells per liter Standard Deviation 205.16	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC) WBC	-0.174 10^9 cells per liter Standard Deviation 0.981	—

SECONDARY outcome

Timeframe: Baseline and Day 10

Population: Safety population.

Blood samples were collected for the analysis of hematology parameters including lymphocytes, neutrophils, platelets, basophils, eosinophils, monocytes, erythrocytes and WBCs at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Lymphocytes	-0.202 10^9 cells per liter Standard Deviation 0.339	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Neutrophils	-0.127 10^9 cells per liter Standard Deviation 0.659	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Platelets	-5.7 10^9 cells per liter Standard Deviation 28.24	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Basophils	-0.004 10^9 cells per liter Standard Deviation 0.012	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Eosinophils	0.003 10^9 cells per liter Standard Deviation 0.057	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Monocytes	-0.014 10^9 cells per liter Standard Deviation 0.130	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC Erythrocytes	76.0 10^9 cells per liter Standard Deviation 165.83	—
Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC WBC	-0.366 10^9 cells per liter Standard Deviation 0.846	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of hematocrit at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Hematocrit When Single Oral Dose of Nemiralisib 100 mcg Administered	1.94 Percentage of red blood cells in blood Standard Deviation 2.067	—

SECONDARY outcome

Timeframe: Baseline and Day 10

Population: Safety population.

Blood samples were collected for the analysis of hematocrit at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Hematocrit When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg	0.14 Percentage of red blood cells in blood Standard Deviation 1.436	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of hemoglobin at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Hemoglobin When Single Oral Dose of Nemiralisib 100 mcg Administered	7.3 Grams per liter Standard Deviation 6.00	—

SECONDARY outcome

Timeframe: Baseline and Day 10

Population: Safety population.

Blood samples were collected for the analysis of hemoglobin at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Hemoglobin When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg	1.9 Grams per liter Standard Deviation 4.42	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of MCH at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (MCH) When Single Oral Dose of Nemiralisib 100 mcg Administered	-0.03 Picograms per liter Standard Deviation 0.459	—

SECONDARY outcome

Timeframe: Baseline and Day 10

Population: Safety population.

Blood samples were collected for the analysis of MCH at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in MCH When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg	-0.12 Picograms per liter Standard Deviation 0.387	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of MCV at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) When Single Oral Dose of Nemiralisib 100 mcg Administered	-0.47 Femtoliter Standard Deviation 0.889	—

SECONDARY outcome

Timeframe: Baseline and Day 10

Population: Safety population.

Blood samples were collected for the analysis of MCV at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in MCV When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg	-1.09 Femtoliter Standard Deviation 0.972	—

SECONDARY outcome

Timeframe: Baseline and Day 6

Population: Safety population.

Blood samples were collected for the analysis of reticulocyte percentage at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Reticulocyte Percentage When Single Oral Dose of Nemiralisib 100 mcg Administered	-0.038 Percentage Standard Deviation 0.302	—

SECONDARY outcome

Timeframe: Baseline and Day 10

Population: Safety population.

Blood samples were collected for the analysis of reticulocyte percentage at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Change From Baseline in Reticulocyte Percentage When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg	0.065 Percentage Standard Deviation 0.267	—

SECONDARY outcome

Timeframe: Days -1, 6 and 10

Population: Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Urine samples were collected for analysis of specific gravity of urine. Urinary specific gravity is the measure of the concentration solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Specific Gravity at Indicated Time Points Day -1, n=20, 19	1.0198 Grams per cubic centimeter Standard Deviation 0.00713	1.0207 Grams per cubic centimeter Standard Deviation 0.00863
Specific Gravity at Indicated Time Points Day 6, n=20, 0	1.0188 Grams per cubic centimeter Standard Deviation 0.00614	—
Specific Gravity at Indicated Time Points Day 10, n=0, 20	—	1.0175 Grams per cubic centimeter Standard Deviation 0.00583

SECONDARY outcome

Timeframe: Days -1, 6 and 10

Population: Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as Trace and 2+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Number of Participants With Abnormal Urinalysis Parameter Ketones, Day -1, Trace, n=20,19	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Protein, Day -1, Trace, n=20,19	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Erythrocytes, Day-1,Trace, n=20,19	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Erythrocytes, Day-1,2+, n=20,19	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Leukocytes, Day 6, Trace, n=20,0	2 Participants	—
Number of Participants With Abnormal Urinalysis Parameter Leukocytes, Day 6, 2+, n=20,0	1 Participants	—

SECONDARY outcome

Timeframe: Day -1, 6 and 10

Population: Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day -1, pH=5, n=20,19	8 Participants	8 Participants
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day -1, pH=6, n=20,19	9 Participants	8 Participants
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day -1, pH=7, n=20,19	2 Participants	3 Participants
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day -1, pH=8, n=20,19	1 Participants	0 Participants
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day 6, pH=5, n=20,0	9 Participants	—
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day 6, pH=6, n=20,0	8 Participants	—
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day 6, pH=7, n=20,0	3 Participants	—
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day 10, pH=5, n=0,20	—	9 Participants
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day 10, pH=6, n=0,20	—	4 Participants
Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points Day 10, pH=7, n=0,20	—	7 Participants

SECONDARY outcome

Timeframe: Day -1

Population: Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

A microscopic examination was performed as part of a routine urinalysis. The microscopic exam was performed on urine sediment - urine was centrifuged to concentrate the substances in it at the bottom of a tube. The fluid at the top of the tube was then discarded and the drops of fluid remaining were examined under a microscope. Cells, crystals, and other substances were counted and reported either as the number observed "per low power field" (LPF) or "per high power field" (HPF).

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Cast0, n=2,2	1 Participants	0 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Cast2, n=2,2	0 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Cast3, n=2,2	1 Participants	0 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Cast10, n=2,2	0 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Epithelial cells 0, n=2,2	2 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Epithelial cells 1, n=2,2	0 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Erythrocytes 1, n=2,2	1 Participants	0 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Erythrocytes 3, n=2,2	0 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Erythrocytes 7, n=2,2	1 Participants	0 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Erythrocytes 9, n=2,2	0 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Leukocytes 1, n=2,2	2 Participants	1 Participants
Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes Leukocytes 2, n=2,2	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Period 1: Up to Day 6; Period 2: Up to Day 10

Population: Safety population.

Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal clinically significant ECG findings for worst case post-Baseline is presented.

Outcome measures

Outcome measures
Measure	Nemiralisib 100 mcg n=20 Participants Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Itraconazole 200 mg and 100mcg Nemiralisib on Day 5 n=20 Participants After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings	0 Participants	0 Participants

Adverse Events

Nemiralisib 100 mcg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nemiralisib 100 mcg With Itraconazole 200 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nemiralisib 100 mcg n=20 participants at risk Participants received a single inhaled oral dose of 100 microgram (mcg) nemiralisib on Day 1 of Period 1 followed by a washout period of 14 days.	Nemiralisib 100 mcg With Itraconazole 200 mg n=20 participants at risk After a washout period of 14 days, participants received a single oral dose of 200 mg Itraconazole from Days 1 to 10. On Day 5, they received a single inhaled oral dose of 100 mcg nemiralisib one hour after the dose of 200 mg Itraconazole.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.	10.0% 2/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.
Ear and labyrinth disorders Hypoacusis	0.00% 0/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.	5.0% 1/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.
Eye disorders Dry eye	0.00% 0/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.	5.0% 1/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.
Nervous system disorders Headache	5.0% 1/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.	0.00% 0/20 • Serious adverse events (SAEs) and adverse events (AEs) were collected up to Day 35 AEs and SAEs were collected in the Safety Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER