Trial Outcomes & Findings for Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation (NCT NCT05627518)

NCT ID: NCT05627518

Last Updated: 2025-04-03

Results Overview

The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan, comparing test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased with the new formulation.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 67 participants
• Primary outcome timeframe: From pre-dose up to 72 h post dose
• Results posted on: 2025-04-03

Participant Flow

Subjects were recruited form CRS's database of healthy volunteers. All Volunteers were recruited in Slovenia, Ljubljana.

Approximately 84 healthy volunteers were planned to be screened to achieve 54 randomized subjects. 97 Volunteers were actually screened for eligibility, of those, 67 were Randomized and 49 Analyzed.

Participant milestones

Measure	Treatment Sequence A B C Treatments A = 100 mg reference formulation (formulation A) non-fasted B = 100 mg test formulation (formulation B) non-fasted C = 100 mg test formulation (formulation B) fasted	Treatment Sequence A C B Treatments A = 100 mg reference formulation (formulation A) non-fasted C = 100 mg test formulation (formulation B) fasted B = 100 mg test formulation (formulation B) non-fasted	Treatment Sequence B A C Treatments B = 100 mg test formulation (formulation B) non-fasted A = 100 mg reference formulation (formulation A) non-fasted C = 100 mg test formulation (formulation B) fasted	Treatment Sequence B C A Treatments B = 100 mg test formulation (formulation B) non-fasted C = 100 mg test formulation (formulation B) fasted A = 100 mg reference formulation (formulation A) non-fasted	Treatment Sequence C A B Treatments C = 100 mg test formulation (formulation B) fasted A = 100 mg reference formulation (formulation A) non-fasted B = 100 mg test formulation (formulation B) non-fasted	Treatment Sequence C B A Treatment C = 100 mg test formulation (formulation B) fasted B = 100 mg test formulation (formulation B) non-fasted A = 100 mg reference formulation (formulation A) non-fasted	Exploratory Arm A B C Subjects underdosed when receiving treatment A, receiving only 1x25 mg LG instead of 4x25. Subjects were excluded from the PK analysis set and their data are instead presented here as exploratory. Treatment sequence as in the title.	Exploratory Arm A C B Subjects underdosed when receiving treatment A, receiving only 1x25 mg LG instead of 4x25. Subjects were excluded from the PK analysis set and their data are instead presented here as exploratory. Treatment sequence as in the title.
Treatment Period 1 STARTED	9	9	9	9	9	9	6	7
Treatment Period 1 COMPLETED	9	9	7	9	9	8	0	0
Treatment Period 1 NOT COMPLETED	0	0	2	0	0	1	6	7
Treatment Period 2 STARTED	9	9	7	9	9	8	0	0
Treatment Period 2 COMPLETED	7	9	7	9	9	8	0	0
Treatment Period 2 NOT COMPLETED	2	0	0	0	0	0	0	0
Treatment Period 3 STARTED	7	9	7	9	9	8	0	0
Treatment Period 3 COMPLETED	7	9	7	9	9	8	0	0
Treatment Period 3 NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Treatment Sequence A B C Treatments A = 100 mg reference formulation (formulation A) non-fasted B = 100 mg test formulation (formulation B) non-fasted C = 100 mg test formulation (formulation B) fasted	Treatment Sequence A C B Treatments A = 100 mg reference formulation (formulation A) non-fasted C = 100 mg test formulation (formulation B) fasted B = 100 mg test formulation (formulation B) non-fasted	Treatment Sequence B A C Treatments B = 100 mg test formulation (formulation B) non-fasted A = 100 mg reference formulation (formulation A) non-fasted C = 100 mg test formulation (formulation B) fasted	Treatment Sequence B C A Treatments B = 100 mg test formulation (formulation B) non-fasted C = 100 mg test formulation (formulation B) fasted A = 100 mg reference formulation (formulation A) non-fasted	Treatment Sequence C A B Treatments C = 100 mg test formulation (formulation B) fasted A = 100 mg reference formulation (formulation A) non-fasted B = 100 mg test formulation (formulation B) non-fasted	Treatment Sequence C B A Treatment C = 100 mg test formulation (formulation B) fasted B = 100 mg test formulation (formulation B) non-fasted A = 100 mg reference formulation (formulation A) non-fasted	Exploratory Arm A B C Subjects underdosed when receiving treatment A, receiving only 1x25 mg LG instead of 4x25. Subjects were excluded from the PK analysis set and their data are instead presented here as exploratory. Treatment sequence as in the title.	Exploratory Arm A C B Subjects underdosed when receiving treatment A, receiving only 1x25 mg LG instead of 4x25. Subjects were excluded from the PK analysis set and their data are instead presented here as exploratory. Treatment sequence as in the title.
Treatment Period 1 Adverse Event	0	0	1	0	0	0	0	1
Treatment Period 1 Withdrawal by Subject	0	0	1	0	0	1	0	0
Treatment Period 1 Protocol Violation	0	0	0	0	0	0	6	6
Treatment Period 2 Adverse Event	1	0	0	0	0	0	0	0
Treatment Period 2 Withdrawal by Subject	1	0	0	0	0	0	0	0

Baseline Characteristics

In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.

Baseline characteristics by cohort

Measure	Treatment Sequence A B C n=15 Participants Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted	Treatment A C B n=15 Participants Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted	Treatment B A C n=9 Participants Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted	Treatment B C A n=10 Participants Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted	Treatment C A B n=9 Participants Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted	Treatment C B A n=9 Participants Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	9 Participants n=8 Participants	67 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	22.2 years n=5 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.	24.3 years n=7 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.	26.4 years n=5 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.	21.5 years n=4 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.	29.6 years n=21 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.	22.3 years n=8 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.	24.1 years n=8 Participants • In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	3 Participants n=8 Participants	35 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	32 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	9 Participants n=8 Participants	66 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment Slovenia	15 participants n=5 Participants	15 participants n=7 Participants	9 participants n=5 Participants	10 participants n=4 Participants	9 participants n=21 Participants	9 participants n=8 Participants	67 participants n=8 Participants

PRIMARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK Analysis Set

The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan, comparing test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased with the new formulation.

Outcome measures

Measure	Reference Formulation (Treatment A) n=51 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=53 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratios of AUCinf and AUClast AUCinf	12341 hours * nmol/Liter Standard Deviation 1.51	25001 hours * nmol/Liter Standard Deviation 1.32
Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratios of AUCinf and AUClast AUClast	10016.2 hours * nmol/Liter Standard Deviation 2.78	24175.8 hours * nmol/Liter Standard Deviation 1.34

PRIMARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK analysis set

The Ratio of Cmax (highest measured concentration) of linaprazan comparing the test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased with the new formulation.

Outcome measures

Measure	Reference Formulation (Treatment A) n=51 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=53 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratio of Cmax	1430 nmol/L Standard Deviation 1.83	3462.2 nmol/L Standard Deviation 1.25

PRIMARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK Analysis Set.

The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan, comparing test formulation vs reference formulation (treatments C vs treatment B) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased in a fed vs fasted state.

Outcome measures

Measure	Reference Formulation (Treatment A) n=53 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=50 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf and AUClast AUCinf	25001 hours * nmol/Liter Standard Deviation 1.32	19448.9 hours * nmol/Liter Standard Deviation 1.32
Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf and AUClast AUClast	24175.8 hours * nmol/Liter Standard Deviation 1.34	19022.8 hours * nmol/Liter Standard Deviation 1.32

PRIMARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK analysis set

The Ratio of Cmax of linaprazan when comparing test formulation vs reference formulation (treatments C vs treatment B), i.e. how much linaprazan exposure is increased or decreased with the new formulation.

Outcome measures

Measure	Reference Formulation (Treatment A) n=53 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=50 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for Cmax	3462.2 nmol/L Standard Deviation 1.25	1608 nmol/L Standard Deviation 1.29

SECONDARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK Analysis Set

The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprzan glurate, comparing test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.

Outcome measures

Measure	Reference Formulation (Treatment A) n=51 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=53 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Glurate for the Test Formulation vs. Reference Formulation of Linaprazan Glurate, Based on the Means Ratios of PK Parameters. AUCinf	114.2 hours * nmol/Liter Standard Deviation 1.95	320.2 hours * nmol/Liter Standard Deviation 1.73
Relative Bioavailability of Linaprazan Glurate for the Test Formulation vs. Reference Formulation of Linaprazan Glurate, Based on the Means Ratios of PK Parameters. AUClast	83.9 hours * nmol/Liter Standard Deviation 2.49	293 hours * nmol/Liter Standard Deviation 1.84

SECONDARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK Analysis Set

The Ratio of Cmax (highest measured concentration) of linaprazan glurate comparing the test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.

Outcome measures

Measure	Reference Formulation (Treatment A) n=51 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=53 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Glurate Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratio of Cmax	86.8 nmol/L Standard Deviation 2.44	214.3 nmol/L Standard Deviation 2.08

SECONDARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK Analysis Set.

The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan glurate, comparing test formulation vs reference formulation (treatments C vs treatment B) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased in a fed vs fasted state.

Outcome measures

Measure	Reference Formulation (Treatment A) n=53 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=50 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf, AUClast AUCinf	320.2 hours * nmol/Liter Standard Deviation 1.73	166.3 hours * nmol/Liter Standard Deviation 1.52
Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf, AUClast AUClast	293.0 hours * nmol/Liter Standard Deviation 1.84	144.3 hours * nmol/Liter Standard Deviation 1.62

SECONDARY outcome

Timeframe: From pre-dose up to 72 h post dose

Population: PK Analysis Set.

The Ratio of Cmax of linaprazan glurate when comparing test formulation vs reference formulation (treatments C vs treatment B), i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.

Outcome measures

Measure	Reference Formulation (Treatment A) n=53 Participants 4 x 25 mg linaprazan glurate reference formulation, fasting conditions	Test Formulation (Treatment B) n=50 Participants 100 mg linaprazan glurate test formulation, fasting conditions Linaprazan glurate: 100 mg
Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratio of Cmax	214.3 nmol/L Standard Deviation 2.08	55.0 nmol/L Standard Deviation 2.23

Adverse Events

Reference Formulation (Treatment A)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Test Formulation (Treatment B)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Test Formulation (Treatment C)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Reference

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reference Formulation (Treatment A) n=51 participants at risk 100 mg linaprazan glurate reference formulation (4x25 mg), fasting conditions Linaprazan glurate: 100 mg	Test Formulation (Treatment B) n=53 participants at risk 100 mg linaprazan glurate reference formulation (1x100 mg), fasting conditions Linaprazan glurate: 100 mg	Test Formulation (Treatment C) n=50 participants at risk 100 mg linaprazan glurate test formulation (1x100 mg), fed conditions Linaprazan glurate: 100 mg	Reference n=13 participants at risk 25 mg linaprazan glurate reference formulation fasting conditions
Skin and subcutaneous tissue disorders Skin Bacterial Infection	0.00% 0/51 • Baseline to Visit 5, 1 month	1.9% 1/53 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month

Other adverse events

Measure	Reference Formulation (Treatment A) n=51 participants at risk 100 mg linaprazan glurate reference formulation (4x25 mg), fasting conditions Linaprazan glurate: 100 mg	Test Formulation (Treatment B) n=53 participants at risk 100 mg linaprazan glurate reference formulation (1x100 mg), fasting conditions Linaprazan glurate: 100 mg	Test Formulation (Treatment C) n=50 participants at risk 100 mg linaprazan glurate test formulation (1x100 mg), fed conditions Linaprazan glurate: 100 mg	Reference n=13 participants at risk 25 mg linaprazan glurate reference formulation fasting conditions
Cardiac disorders Tachycardia	5.9% 3/51 • Number of events 4 • Baseline to Visit 5, 1 month	5.7% 3/53 • Number of events 3 • Baseline to Visit 5, 1 month	2.0% 1/50 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Gastrointestinal disorders Diarrhoea	3.9% 2/51 • Number of events 2 • Baseline to Visit 5, 1 month	0.00% 0/53 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Gastrointestinal disorders Vomiting	3.9% 2/51 • Number of events 2 • Baseline to Visit 5, 1 month	0.00% 0/53 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Gastrointestinal disorders Constipation	2.0% 1/51 • Number of events 1 • Baseline to Visit 5, 1 month	3.8% 2/53 • Number of events 2 • Baseline to Visit 5, 1 month	2.0% 1/50 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Infections and infestations Nasopharyngitis	5.9% 3/51 • Number of events 3 • Baseline to Visit 5, 1 month	0.00% 0/53 • Baseline to Visit 5, 1 month	8.0% 4/50 • Number of events 4 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Infections and infestations Rhinitis	0.00% 0/51 • Baseline to Visit 5, 1 month	3.8% 2/53 • Number of events 2 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Investigations Blood pressure diastolic inceased	2.0% 1/51 • Number of events 1 • Baseline to Visit 5, 1 month	1.9% 1/53 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Nervous system disorders Headache	5.9% 3/51 • Number of events 3 • Baseline to Visit 5, 1 month	1.9% 1/53 • Number of events 1 • Baseline to Visit 5, 1 month	4.0% 2/50 • Number of events 2 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Nervous system disorders Sciatica	0.00% 0/51 • Baseline to Visit 5, 1 month	1.9% 1/53 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Skin and subcutaneous tissue disorders Papula	0.00% 0/51 • Baseline to Visit 5, 1 month	0.00% 0/53 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	15.4% 2/13 • Number of events 2 • Baseline to Visit 5, 1 month
Skin and subcutaneous tissue disorders Vascular disorders	2.0% 1/51 • Number of events 1 • Baseline to Visit 5, 1 month	3.8% 2/53 • Number of events 2 • Baseline to Visit 5, 1 month	6.0% 3/50 • Number of events 3 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Vascular disorders Hypertension	2.0% 1/51 • Number of events 1 • Baseline to Visit 5, 1 month	1.9% 1/53 • Number of events 1 • Baseline to Visit 5, 1 month	2.0% 1/50 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Vascular disorders Phlebitis	0.00% 0/51 • Baseline to Visit 5, 1 month	1.9% 1/53 • Number of events 1 • Baseline to Visit 5, 1 month	4.0% 2/50 • Number of events 2 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	2.0% 1/51 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/53 • Baseline to Visit 5, 1 month	0.00% 0/50 • Baseline to Visit 5, 1 month	15.4% 2/13 • Number of events 2 • Baseline to Visit 5, 1 month
Cardiac disorders Cardiac disorders	7.8% 4/51 • Number of events 5 • Baseline to Visit 5, 1 month	5.7% 3/53 • Number of events 3 • Baseline to Visit 5, 1 month	2.0% 1/50 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month
Hepatobiliary disorders Liver disorder	0.00% 0/51 • Baseline to Visit 5, 1 month	0.00% 0/53 • Baseline to Visit 5, 1 month	2.0% 1/50 • Number of events 1 • Baseline to Visit 5, 1 month	0.00% 0/13 • Baseline to Visit 5, 1 month

Additional Information

Kristofer Katkits Nilsson, Global Trial Manager

Cinclus Pharma AB

Phone: +46 7064955

Email: kristofer.katkits@cincluspharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60