Trial Outcomes & Findings for A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar (NCT NCT01197911)

NCT ID: NCT01197911

Last Updated: 2015-12-24

Results Overview

AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 38 participants
• Primary outcome timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose
• Results posted on: 2015-12-24

Participant Flow

A total of 38 participants with normal hepatic function, or with mild or moderate hepatic impairment were enrolled from 30 September 2010 to 05 August 2011 at 2 study sites in the U. S.

Participant milestones

Measure	Normal Hepatic Function Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Overall Study STARTED	18	10	10
Overall Study COMPLETED	18	10	9
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Normal Hepatic Function Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Overall Study Adverse Event	0	0	1

Baseline Characteristics

A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar

Baseline characteristics by cohort

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Total n=38 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 5.36 • n=5 Participants	46.7 years STANDARD_DEVIATION 8.39 • n=7 Participants	52.8 years STANDARD_DEVIATION 6.14 • n=5 Participants	49.3 years STANDARD_DEVIATION 6.69 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.

AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar	98.5 hours (h)*nanogram (ng)/milliliter (mL) Geometric Coefficient of Variation 27.2	113 hours (h)*nanogram (ng)/milliliter (mL) Geometric Coefficient of Variation 41.8	151 hours (h)*nanogram (ng)/milliliter (mL) Geometric Coefficient of Variation 29.6

PRIMARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.

Cmax was obtained directly from the concentration-time data.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Maximum Plasma Concentration (Cmax) of Aleglitazar	21.2 ng/mL Geometric Coefficient of Variation 30.3	20.1 ng/mL Geometric Coefficient of Variation 25.8	22.1 ng/mL Geometric Coefficient of Variation 24.4

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
AUCinf of M1 (RO4408754) and M6 (RO4583746) M1 (n = 18, 9, 9)	14.0 h*ng/mL Geometric Coefficient of Variation 32.9	17.1 h*ng/mL Geometric Coefficient of Variation 29.5	24.9 h*ng/mL Geometric Coefficient of Variation 22.4
AUCinf of M1 (RO4408754) and M6 (RO4583746) M6 (n = 18, 10, 9)	148 h*ng/mL Geometric Coefficient of Variation 27.8	169 h*ng/mL Geometric Coefficient of Variation 54.3	247 h*ng/mL Geometric Coefficient of Variation 35.2

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Cmax was obtained directly from the concentration-time data.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Cmax of M1 and M6 M1 (n=18, 9, 9)	2.00 ng/mL Geometric Coefficient of Variation 25.7	2.01 ng/mL Geometric Coefficient of Variation 40.8	2.38 ng/mL Geometric Coefficient of Variation 27.1
Cmax of M1 and M6 M6 (n= 18, 10, 9)	4.59 ng/mL Geometric Coefficient of Variation 24.5	4.05 ng/mL Geometric Coefficient of Variation 54.4	4.05 ng/mL Geometric Coefficient of Variation 19.7

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUC0-48 was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6 Aleglitazar (n = 18, 10, 10)	97.3 h*ng/mL Geometric Coefficient of Variation 27.0	111 h*ng/mL Geometric Coefficient of Variation 39.6	149 h*ng/mL Geometric Coefficient of Variation 28.6
Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6 M1 (n = 18, 9, 9)	13.8 h*ng/mL Geometric Coefficient of Variation 31.6	16.4 h*ng/mL Geometric Coefficient of Variation 29.5	24.0 h*ng/mL Geometric Coefficient of Variation 20.9
Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6 M6 (n = 18, 10, 9)	112 h*ng/mL Geometric Coefficient of Variation 25.4	115 h*ng/mL Geometric Coefficient of Variation 52.7	137 h*ng/mL Geometric Coefficient of Variation 17.4

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

AUClast was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6 Aleglitazar (n= 18, 10, 10)	97.5 h*ng/mL Geometric Coefficient of Variation 27.6	112 h*ng/mL Geometric Coefficient of Variation 41.6	150 h*ng/mL Geometric Coefficient of Variation 29.6
Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6 M1 (n= 18, 10, 10)	12.5 h*ng/mL Geometric Coefficient of Variation 32.4	15.2 h*ng/mL Geometric Coefficient of Variation 29.6	22.3 h*ng/mL Geometric Coefficient of Variation 23.6
Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6 M6 (n= 18, 10, 10)	137 h*ng/mL Geometric Coefficient of Variation 27.2	151 h*ng/mL Geometric Coefficient of Variation 52.0	186 h*ng/mL Geometric Coefficient of Variation 35.6

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.

CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Apparent Total Body Clearance (CL/F) of Aleglitazar	1.52 L/h Geometric Coefficient of Variation 27.2	1.33 L/h Geometric Coefficient of Variation 41.8	0.990 L/h Geometric Coefficient of Variation 29.6

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72, and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time 0 to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Renal Clearance (CLR) of Aleglitazar, M1, and M6 Aleglitazar (n = 18, 10, 9)	NA L/h Geometric Coefficient of Variation NA CLR of aleglitazar was not calculable since amount excreted in urine was below limit of quantification.	NA L/h Geometric Coefficient of Variation NA CLR of aleglitazar was not calculable since amount excreted in urine was below limit of quantification.	NA L/h Geometric Coefficient of Variation NA CLR of aleglitazar was not calculable since amount excreted in urine was below limit of quantification.
Renal Clearance (CLR) of Aleglitazar, M1, and M6 M1 (n = 18, 9, 9)	0.994 L/h Geometric Coefficient of Variation 68.5	1.26 L/h Geometric Coefficient of Variation 48.5	0.857 L/h Geometric Coefficient of Variation 46.6
Renal Clearance (CLR) of Aleglitazar, M1, and M6 M6 (n = 18, 10, 9)	0.0427 L/h Geometric Coefficient of Variation 31.4	0.0565 L/h Geometric Coefficient of Variation 28.4	0.0454 L/h Geometric Coefficient of Variation 19.9

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

Plasma and urine samples were collected for this PK parameter. CLNR/F was estimated as CL/F, based on the approximated formula of CLNR/F = (CL-CLR)/F with CLR of aleglitazar being equal to zero. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time zero to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Apparent Non-renal Clearance (CLNR/F) of Aleglitazar	1.52 L/h Geometric Coefficient of Variation 27.2	1.33 L/h Geometric Coefficient of Variation 41.8	0.991 L/h Geometric Coefficient of Variation 31.5

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.

M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Tmax was measured as time to reach the maximum concentration in the plasma after post-dose.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6 Aleglitazar	1.00 h Interval 0.5 to 2.0	1.00 h Interval 0.5 to 3.0	1.00 h Interval 0.5 to 2.0
Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6 M1	2.01 h Interval 1.0 to 5.0	3.50 h Interval 2.0 to 5.0	4.00 h Interval 2.0 to 5.0
Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6 M6	9.00 h Interval 5.0 to 12.0	9.00 h Interval 5.0 to 15.0	24.0 h Interval 9.0 to 24.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

M1 and M6 are pharmacologically inactive metabolites of aleglitazar. T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6 Aleglitazar (n = 18, 10, 10)	7.59 h Geometric Coefficient of Variation 31.3	8.18 h Geometric Coefficient of Variation 29.1	8.04 h Geometric Coefficient of Variation 19.3
Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6 M1 (n = 18, 9, 9)	6.11 h Geometric Coefficient of Variation 55.0	7.79 h Geometric Coefficient of Variation 57.4	9.37 h Geometric Coefficient of Variation 31.7
Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6 M6 (n = 18, 10, 9)	25.6 h Geometric Coefficient of Variation 17.4	27.1 h Geometric Coefficient of Variation 19.4	35.1 h Geometric Coefficient of Variation 28.4

SECONDARY outcome

Timeframe: 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.

The kel is fraction of a substance that is removed per unit time measured at any particular instant. It was calculated using at least 3 concentration-time points and ideally covered more than 2 half-lives.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Elimination Rate Constant (Kel) of Aleglitazar	0.0914 1/h Geometric Coefficient of Variation 31.3	0.0847 1/h Geometric Coefficient of Variation 29.1	0.0862 1/h Geometric Coefficient of Variation 19.3

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.

Vz/F is the apparent volume of distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Apparent Volume of Distribution (Vz/F) of Aleglitazar	16.7 L Geometric Coefficient of Variation 30.7	15.7 L Geometric Coefficient of Variation 22.5	11.5 L Geometric Coefficient of Variation 17.0

SECONDARY outcome

Timeframe: 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.

The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours, where Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6 Aleglitazar (n = 18, 10, 9)	NA mcg Geometric Coefficient of Variation NA Ae0-48 of aleglitazar was not calculable since amount excreted in urine was below limit of quantification.	NA mcg Geometric Coefficient of Variation NA Ae0-48 of aleglitazar was not calculable since amount excreted in urine was below limit of quantification.	NA mcg Geometric Coefficient of Variation NA Ae0-48 of aleglitazar was not calculable since amount excreted in urine was below limit of quantification.
Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6 M1 (n = 18, 10, 10)	13.7 mcg Geometric Coefficient of Variation 49.1	21.1 mcg Geometric Coefficient of Variation 31.8	20.5 mcg Geometric Coefficient of Variation 47.0
Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6 M6 (n = 18, 10, 10)	4.78 mcg Geometric Coefficient of Variation 39.7	6.48 mcg Geometric Coefficient of Variation 53.2	5.81 mcg Geometric Coefficient of Variation 37.3

SECONDARY outcome

Timeframe: 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

fe0-48 was calculated as Ae0-48/dose. The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours. Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=9 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Fraction of Drug Excreted in Urine From Time 0 to 48 Hours Post-dose (fe0-48) of Aleglitazar	NA mcg Geometric Coefficient of Variation NA Ae0-48 and fe0-48 of aleglitazar was not calculable (NC) since amount excreted in urine was below limit of quantification.	NA mcg Geometric Coefficient of Variation NA Ae0-48 and fe0-48 of aleglitazar was not calculable (NC) since amount excreted in urine was below limit of quantification.	NA mcg Geometric Coefficient of Variation NA Ae0-48 and fe0-48 of aleglitazar was not calculable (NC) since amount excreted in urine was below limit of quantification.

SECONDARY outcome

Timeframe: 2 and 24 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

fu was calculated using the mean of the 2-hour (reflecting Cmax) and 24-hour (reflecting Ctrough) values for each participant or, if the result of only one time-point was available, fu was the result of the available time-point. Ctrough) is a measured concentration at the end of a dosing interval at steady state.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Mean of Fraction of Unbound Aleglitazar (fu)	0.101 Percentage Geometric Coefficient of Variation 10.2	0.111 Percentage Geometric Coefficient of Variation 7.4	0.114 Percentage Geometric Coefficient of Variation 15.3

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. It was assessed using an analysis of variance model on the log-transformed values of AUCinf of aleglitazar with hepatic impairment group as factor.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to Infinity (AUCu,Inf)	0.0992 h*ng/mL Geometric Coefficient of Variation 27.0	0.122 h*ng/mL Geometric Coefficient of Variation 44.5	0.160 h*ng/mL Geometric Coefficient of Variation 30.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

Cmax was obtained directly from the concentration-time data.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Maximum Unbound Plasma Concentration (Cmax,u) of Aleglitazar	0.0213 ng/mL Geometric Coefficient of Variation 30.4	0.0214 ng/mL Geometric Coefficient of Variation 27.4	0.0257 ng/mL Geometric Coefficient of Variation 17.2

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

Plasma samples were collected for this PK parameter. AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero 0 to the last quantifiable time-point post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. AUClast was extrapolated to AUCinf by adding the ratio of Clast/kel to the AUClast, where Clast was the last observed concentration and kel was elimination rate constant.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From 0 to the Last Quantifiable Time-point Post-dose (AUCu,Last)	0.0981 h*ng/mL Geometric Coefficient of Variation 27.3	0.121 h*ng/mL Geometric Coefficient of Variation 44.4	0.158 h*ng/mL Geometric Coefficient of Variation 29.6

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to 48 Hours Post-dose (AUCu,0-48)	0.0980 h*ng/mL Geometric Coefficient of Variation 26.7	0.120 h*ng/mL Geometric Coefficient of Variation 40.9	0.158 h*ng/mL Geometric Coefficient of Variation 29.2

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.

VzF/u is an apparent volume of Unbound distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Apparent Unbound Volume of Distribution (Vz/Fu) of Aleglitazar	16600 L Geometric Coefficient of Variation 29.3	14500 L Geometric Coefficient of Variation 19.6	10600 L Geometric Coefficient of Variation 23.2

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine

Population: The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific study drug/metabolite were analyzed.

CL/F is an apparent total clearance of the drug from plasma after oral administration. It was calculated as dose/AUCinf. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=6 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=7 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Apparent Unbound Total Body Clearance (CL/Fu) of Aleglitazar	1510 L/h Geometric Coefficient of Variation 27.0	1230 L/h Geometric Coefficient of Variation 44.5	939 L/h Geometric Coefficient of Variation 30.0

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation Any AEs	3 participants	0 participants	2 participants
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation Any SAEs	0 participants	0 participants	1 participants
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation Death	0 participants	0 participants	0 participants
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation Study discontinuation	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Screening (Days -28 to -2), baseline (Day -1), Days 1 to 5, and follow-up visit (Day 10)

Population: The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.

The ECG evaluations were performed after participants were at rest and in supine position for at least 5 minutes before recording and remain resting and supine during the recordings. ECGs parameters included heart rate (HR), RR interval, PR interval, QRS duration, QT interval, QTcB, and QTcF intervals. The normal ranges of ECG parameter values were: HR as 40-100 beats per minute, RR as 600-1500 milliseconds (msec), PR as 120-200 msec, QRS as 80-120 msec, QT as 200-500 msec, QTcB as 350-450 msec, and QTcF as 350-450 msec. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values HR - high	1 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values HR - low	0 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values RR - high	0 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values RR - low	1 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values PR - high	1 participants	1 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values PR - low	2 participants	0 participants	3 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QRS - high	0 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QRS - low	6 participants	1 participants	6 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QT - high	1 participants	1 participants	1 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QT - low	0 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QTcB - high	2 participants	3 participants	4 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QTcB - low	0 participants	0 participants	0 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QTcF - high	2 participants	2 participants	3 participants
Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values QTcF - low	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Days -28 to -2, Day -1, Days 1 to 5, and Day 10 for blood pressure and pulse rate; and Days -28 to -2, Day -1, and Day 10 for oral body temperature

Population: The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.

Vital signs were assessed after participants had rested in a supine position for no less than 5 minutes. Vital signs included systolic blood pressure, diastolic blood pressure, pulse rate, and oral body temperature. The normal ranges of vital signs were: systolic blood pressure as 90-140 millimeter of Hg (mm Hg), diastolic blood pressure as 50-90 mm Hg, pulse rate as 45-100 beats per minute, and oral body temperature as 36.3-37.5 degree Celsius. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Number of Participants With Low and High Vital Signs Values Systolic blood pressure - high	4 participants	4 participants	3 participants
Number of Participants With Low and High Vital Signs Values Systolic blood pressure - low	2 participants	0 participants	2 participants
Number of Participants With Low and High Vital Signs Values Diastolic blood pressure - high	2 participants	3 participants	1 participants
Number of Participants With Low and High Vital Signs Values Diastolic blood pressure - low	1 participants	0 participants	2 participants
Number of Participants With Low and High Vital Signs Values Pulse rate - high	1 participants	0 participants	0 participants
Number of Participants With Low and High Vital Signs Values Pulse rate - low	1 participants	2 participants	1 participants
Number of Participants With Low and High Vital Signs Values Oral body temperature - high	0 participants	0 participants	0 participants
Number of Participants With Low and High Vital Signs Values Oral body temperature - low	11 participants	4 participants	7 participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.

Laboratory parameters included hematology, coagulation, biochemistry, and urinalysis. A marked abnormality was defined as a test result which was outside of the marked abnormality range. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).

Outcome measures

Measure	Normal Hepatic Function n=18 Participants Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 Participants Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 Participants Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters Lymphocytes - low	0 participants	0 participants	1 participants
Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters Bicarbonate - high	0 participants	1 participants	2 participants
Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters Phosphate - high	0 participants	0 participants	1 participants
Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters Blood - high	2 participants	0 participants	3 participants
Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters Glucose - high	0 participants	0 participants	3 participants
Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters Protein - high	0 participants	0 participants	1 participants

Adverse Events

Normal Hepatic Function

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Mild Hepatic Impairment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Hepatic Impairment

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Normal Hepatic Function n=18 participants at risk Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 participants at risk Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 participants at risk Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Gastrointestinal disorders Ascites	0.00% 0/18 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	10.0% 1/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.

Other adverse events

Measure	Normal Hepatic Function n=18 participants at risk Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet	Mild Hepatic Impairment n=10 participants at risk Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet	Moderate Hepatic Impairment n=10 participants at risk Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/18 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	10.0% 1/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.
Nervous system disorders Headache	5.6% 1/18 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.
Surgical and medical procedures Nasal decongestion therapy	5.6% 1/18 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.	0.00% 0/10 • Up to 6 weeks SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received the single dose of the study drug, whether prematurely withdrawn from the study or not.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

Email: global.trial_information@roche.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER