Trial Outcomes & Findings for Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers (NCT NCT06945276)

Results Overview

Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

51 participants

Primary outcome timeframe

Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Results posted on

2026-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Part A Arm A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part B Arm A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24)	Part C Sequence 1 Arm A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5)	Part C Sequence 2 Arm A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5)	Part C Sequence 3 Arm A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)
Overall Study STARTED	12	24	5	5	5
Overall Study COMPLETED	12	23	5	5	5
Overall Study NOT COMPLETED	0	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part C Sequence 3 Arm n=5 Participants A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Total n=51 Participants Total of all reporting groups	Part A n=12 Participants A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part B n=24 Participants A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24).	Part C Sequence 1 Arm n=5 Participants A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5)	Part C Sequence 2 Arm n=5 Participants A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5)
Age, Categorical <=18 years	0 Participants n=312 Participants	1 Participants n=105 Participants	0 Participants n=11 Participants	1 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=312 Participants	50 Participants n=105 Participants	12 Participants n=11 Participants	23 Participants n=9 Participants	5 Participants n=20 Participants	5 Participants n=78 Participants
Age, Categorical >=65 years	0 Participants n=312 Participants	0 Participants n=105 Participants	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants
Sex: Female, Male Female	4 Participants n=312 Participants	32 Participants n=105 Participants	6 Participants n=11 Participants	14 Participants n=9 Participants	4 Participants n=20 Participants	4 Participants n=78 Participants
Sex: Female, Male Male	1 Participants n=312 Participants	19 Participants n=105 Participants	6 Participants n=11 Participants	10 Participants n=9 Participants	1 Participants n=20 Participants	1 Participants n=78 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=312 Participants	0 Participants n=105 Participants	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Asian	0 Participants n=312 Participants	0 Participants n=105 Participants	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=312 Participants	0 Participants n=105 Participants	0 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Black or African American	3 Participants n=312 Participants	25 Participants n=105 Participants	5 Participants n=11 Participants	15 Participants n=9 Participants	1 Participants n=20 Participants	1 Participants n=78 Participants
Race (NIH/OMB) White	2 Participants n=312 Participants	21 Participants n=105 Participants	3 Participants n=11 Participants	8 Participants n=9 Participants	4 Participants n=20 Participants	4 Participants n=78 Participants
Race (NIH/OMB) More than one race	0 Participants n=312 Participants	3 Participants n=105 Participants	2 Participants n=11 Participants	1 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=312 Participants	2 Participants n=105 Participants	2 Participants n=11 Participants	0 Participants n=9 Participants	0 Participants n=20 Participants	0 Participants n=78 Participants

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9

Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for AUC0-inf. The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone n=22 Participants The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=14 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=11 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf): ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B	541 h*ng/mL Geometric Coefficient of Variation 56.8	662 h*ng/mL Geometric Coefficient of Variation 64.5	24800 h*ng/mL Geometric Coefficient of Variation 25.8	25200 h*ng/mL Geometric Coefficient of Variation 25.5	22100 h*ng/mL Geometric Coefficient of Variation 22.4	12800 h*ng/mL Geometric Coefficient of Variation 40.3	41900 h*ng/mL Geometric Coefficient of Variation 47.7

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9

Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for AUClast. The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone n=24 Participants The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=15 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B	495 h*ng/mL Geometric Coefficient of Variation 71.5	638 h*ng/mL Geometric Coefficient of Variation 66.3	24700 h*ng/mL Geometric Coefficient of Variation 25.8	25000 h*ng/mL Geometric Coefficient of Variation 25.5	21900 h*ng/mL Geometric Coefficient of Variation 21.6	11900 h*ng/mL Geometric Coefficient of Variation 44.5	41700 h*ng/mL Geometric Coefficient of Variation 47.8

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9

Drug-drug interactions for t1/2 were evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A and Part C) and dabigatran (Part B)

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone n=22 Participants The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=14 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=11 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Elimination Half-life (t1/2):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B	9.15 Hours Geometric Coefficient of Variation 20.6	9.31 Hours Geometric Coefficient of Variation 23.9	3.47 Hours Geometric Coefficient of Variation 32.3	6.96 Hours Geometric Coefficient of Variation 39.9	3.10 Hours Geometric Coefficient of Variation 9.72	3.19 Hours Geometric Coefficient of Variation 34.3	5.72 Hours Geometric Coefficient of Variation 45.6

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9

Drug-drug interaction in Parts A and B was evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A) and dabigatran (Part B) in the test treatment condition (combined-treatment condition) relative to the reference treatment condition (single-treatment condition) was estimated by ANOVA with the 90% CI calculated for Cmax. The evaluation of the potential food effect on the PK of ALG-097558 and the relative bioavailability assessment of Formulation 2 versus Formulation 1 in Part C was performed in 2 separate 2-treatment ANOVAs.

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone n=24 Participants The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=15 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Maximum Observed Concentration (Cmax):ALG-097558 in Plasma in Part A and Part C, Dabigatran (Total) in Plasma in Part B	58.6 ng/mL Geometric Coefficient of Variation 72.2	80.6 ng/mL Geometric Coefficient of Variation 67.1	4720 ng/mL Geometric Coefficient of Variation 24.7	3470 ng/mL Geometric Coefficient of Variation 21.6	4320 ng/mL Geometric Coefficient of Variation 27.0	2730 ng/mL Geometric Coefficient of Variation 38.9	4850 ng/mL Geometric Coefficient of Variation 35.8

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9

Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) of ALG-097558 (Part A and Part C) and dabigatran (Part B)

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone n=24 Participants The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=15 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Population: Primary PK parameters for ALG-097558 metabolite, ALG-097730, were only analyzed for Part A and Part C.

Drug-drug interactions for AUC0-inf were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=12 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=14 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf) for ALG-097730 Plasma in Part A and Part C	—	—	6530 h*ng/mL Geometric Coefficient of Variation 40.1	6000 h*ng/mL Geometric Coefficient of Variation 34.7	6360 h*ng/mL Geometric Coefficient of Variation 31.9	3140 h*ng/mL Geometric Coefficient of Variation 35.4	7000 h*ng/mL Geometric Coefficient of Variation 36.4

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Population: Primary PK parameters for ALG-097558 metabolite, ALG-097730, were only analyzed for Part A and Part C.

Drug-drug interactions for AUClast were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=15 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097730 in Plasma in Part A and Part C	—	—	6600 h*ng/mL Geometric Coefficient of Variation 36.0	5940 h*ng/mL Geometric Coefficient of Variation 34.8	6200 h*ng/mL Geometric Coefficient of Variation 31.5	3100 h*ng/mL Geometric Coefficient of Variation 35.3	6930 h*ng/mL Geometric Coefficient of Variation 36.6

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Population: Primary PK parameters for ALG-097558 metabolite, ALG-097730, were only analyzed for Part A and Part C.

Drug-drug interactions for t1/2 were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=12 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=14 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Elimination Half-life (t1/2) for ALG-097730 in Plasma in Part A and Part C	—	—	5.43 Hours Geometric Coefficient of Variation 37.6	7.07 Hours Geometric Coefficient of Variation 27.4	6.54 Hours Geometric Coefficient of Variation 51.5	4.95 Hours Geometric Coefficient of Variation 33.3	6.72 Hours Geometric Coefficient of Variation 29.2

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Population: Primary PK parameters for ALG-097558 metabolite, ALG-097730, were only analyzed for Part A and Part C.

Drug-drug interactions for Cmax were evaluated using the geometric mean ratio (log-transformed)in Part A and Part C

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=15 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Maximum Observed Concentration (Cmax) for ALG-097730 in Plasma in Part A and Part C	—	—	1010 ng/mL Geometric Coefficient of Variation 33.5	758 ng/mL Geometric Coefficient of Variation 37.7	983 ng/mL Geometric Coefficient of Variation 38.1	533 ng/mL Geometric Coefficient of Variation 27.5	577 ng/mL Geometric Coefficient of Variation 25.3

PRIMARY outcome

Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9

Population: Primary PK parameters for ALG-097558 metabolite, ALG-097730, were only analyzed for Part A and Part C.

Drug-drug interactions for Tmax were evaluated using the geometric mean ratio (log-transformed) in Part A and Part C

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted n=15 Participants PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed n=15 Participants PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone n=12 Participants Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole n=12 Participants Exposure parameters were compared when ALG-097558 was administered with itraconazole
Time of Observed Maximum Concentration (Tmax) for ALG-097730 in Part A and Part C	—	—	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification

SECONDARY outcome

Timeframe: 0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097558, were only analyzed for Part B.

PK parameter of Cmax was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Maximum Observed Concentration (Cmax) of ALG-097558 in Plasma After Co-administration With a Single Dose of Dabigatran in Part B	—	4060 ng/mL Geometric Coefficient of Variation 28.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097558 were only analyzed for Part B.

PK parameter of Tmax was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B	—	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097558 were only analyzed for Part B

PK parameter of AUClast was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B	—	20800 h*ng/mL Geometric Coefficient of Variation 33.4	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097558 were only analyzed for Part B.

PK parameter of t1/2 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=19 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Elimination Half-life (t1/2) of ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B	—	2.11 Hours Geometric Coefficient of Variation 15.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097558 were only analyzed for Part B.

PK parameter of Tlast was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Time of Last Measurable Concentration (Tlast):ALG-097558 in Plasma After Coadministration With a Single Dose of Dabigatran in Part B	—	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for metabolite ALG-097730, were only analyzed for Part B.

PK parameter of Cmax for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Maximum Observed Concentration (Cmax) of ALG-097730 in Plasma After Co-administration of ALG-097558 With a Single Dose of Dabigatran in Part B	—	897 ng/mL Geometric Coefficient of Variation 28.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097730 were only analyzed for Part B.

PK parameter of Tmax for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Time of Observed Maximum Concentration (Tmax):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B	—	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for metabolite ALG-097730 were only analyzed for Part B

PK parameter of AUClast for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for Metabolite ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B	—	5640 h*ng/mL Geometric Coefficient of Variation 27.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for metabolite ALG-097730, were only analyzed for Part B.

PK parameter of t1/2 for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=19 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Elimination Half-life (t1/2) for Metabolite ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B	—	2.42 Hours Geometric Coefficient of Variation 16.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for ALG-097558 were only analyzed for Part B.

PK parameter of Tlast for metabolite ALG-097730 was assessed following 600 mg ALG 097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Time of Last Measurable Concentration (Tlast):ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B	—	NA Hours Geometric Coefficient of Variation NA It was pre-specified that pharmacokinetic parameters would not be calculated for participants with fewer than 4 quantifiable analyte concentrations after imputations of below the limit of quantification	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B-0 to 72 hours post dose on Days 1 to 8

Population: Secondary steady state PK parameters for metabolite ALG-097730 were only analyzed for Part B.

PK parameter of MPAUClast for metabolite ALG-097730 was assessed following 600 mg ALG-097558 Q12H co-administered with a single 75 mg dabigatran dose

Outcome measures

Outcome measures
Measure	Part B: Dabigatran Dosed Alone The PK parameters for total dabigatran, a P-gp substrate, were compared when a single 75 mg dose of dabigatran was administered alone (Day 1)	Part B: Dabigatran With ALG-097558 n=23 Participants The PK parameters for total dabigatran, a P-gp substrate was compared when co-administered with 600 mg ALG 097558 Q12H (Day 5)	Part C: Formulation 1 Fasted PK parameters were compared after ALG-097558 was administered as the spray-dried dispersion (SDD, Formulation 1)	Part C: Formulation 2 Fasted PK parameters were compared after ALG-097558 was administered as the conventional tablet (Formulation 2) in the fasted state	Part C: Formulation 2 Fed PK parameters were compared after ALG-097558 was administered as the tablet (Formulation 2) after a high-fat meal versus the tablet in the fasted state	Part A: ALG-097558 Dosed Alone Exposure parameters were compared after ALG-097558 was administered alone	Part A: ALG-097558 With Itraconazole Exposure parameters were compared when ALG-097558 was administered with itraconazole
Metabolite to Parent Area Under the Concentration-time Curve Ratio From Time Zero to the Last Measurable Concentration (MPAUClast) for ALG-097730 in Plasma After Coadministration of ALG-097558 With a Single Dose of Dabigatran in Part B	—	0.263 Ratio Geometric Coefficient of Variation 17.4	—	—	—	—	—

Deaths: 0 deaths

Part C Arm-Sequence 3 (Formulation 1 Fasted)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part C Arm-Sequence 3 (Formulation 2 Fasted)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A Arm-Placebo n=12 participants at risk A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part A Arm-ALG-097558 (Alone) n=12 participants at risk A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part A Arm-Itraconazole (Alone) n=12 participants at risk A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part A Arm-Itraconazole + Placebo n=12 participants at risk A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part A Arm-Itraconazole + ALG-097558 n=12 participants at risk A single-blind oral placebo dose will be administered on Day 1. On Day 2, an open-labeled single oral dose of 300 mg of ALG-097558 will be administered as a spay-dried dispersion (SDD) tablet, followed by a washout period of at least 2 days. On Day 4-10 participants will receive a daily oral dose of Itraconazole 200 mg. A single oral dose of matching placebo (SDD tablet) for ALG-097558 will be given on Day 6, and a single oral dose of 300 mg of ALG-097558 SDD tablet will be given on Day 7. (N=12)	Part B Arm-Dabigatran (Alone) n=24 participants at risk A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24)	Part B Arm-ALG-097558 (Alone) n=24 participants at risk A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24)	Part B Arm-ALG-097558 + Dabigatran n=24 participants at risk A single oral dose of 75 mg of dabigatran will be administered on Day 1, in a fasted stated, followed by a washout period of at least 3 days. Participants will then receive multiple oral doses of 600 mg of ALG-097558 Q12H as a spray-dried dispersion (SDD) tablet on Days 4-5, in a fasted state. A single oral dose of 75 mg of dabigatran will be given on Day 5, in a fasted state. (N=24)	Part C Arm-Sequence 1-Formulation 1 Fasted n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 1-Formulation 2 Fasted n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 1-Formulation 2 Fed n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 2 (Formulation 2 Fasted) n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 2 (Formulation 2 Fed) n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 2 (Formulation 1 Fasted) n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 3 (Formulation 2 Fed) n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 3 (Formulation 1 Fasted) n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)	Part C Arm-Sequence 3 (Formulation 2 Fasted) n=5 participants at risk Sequence 1 Arm-A single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state. (N=5) Sequence 2 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a conventional tablet will be administered in the fed state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a spray-dried dispersion (SDD) tablet will be administered in the fasted state. (N=5) Sequence 3 Arm-A single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fed state, followed by a 3-day washout period. On Day 4, a single oral dose of 600 mg of ALG-097558 in a spray-dried dispersion (SDD) tablet will be administered in the fasted state, followed by another 3-day washout period. On Day 7, a single oral dose of 600 mg of ALG-097558, in a conventional tablet will be administered in the fasted state. (N=5)
Gastrointestinal disorders Nausea	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Gastrointestinal disorders Abdominal Pain	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	25.0% 3/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	16.7% 2/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Lipase Increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Low density lipoprotein increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Nervous system disorders Paraesthesia	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Nervous system disorders Somnolence	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 1/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Nervous system disorders Headache	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 2/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Blood triglycerides increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	20.0% 1/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Blood creatinine phosphokinae increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	8.3% 2/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Infections and infestations Pustule	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Alanine aminotransferase increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Glomerular filtration rate decreased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Lipase increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations Neutrophil count increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.
Investigations White blood cell count increased	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/12 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	4.2% 1/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/24 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.	0.00% 0/5 • From signing informed consent through the end of the trial up to 49 days on which part of the trial the participant was enrolled.

Additional Information

Tammy Yokum

NIAID/DMID/OBRRTR

Phone: 240-753-2119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place