Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (NCT NCT06568861)
NCT ID: NCT06568861
Last Updated: 2026-08-05
Results Overview
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only
Results posted on
2026-08-05
Participant Flow
Participants were recruited at 2 investigational sites. The first participant enrolled was on 13-Jan-2025 and the last participant was enrolled on 24-Jun-2025.
During the study a total of 20 participants were screened. 16 participants were enrolled in the study. All 16 participants received the study drug.
Participant milestones
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
Baseline characteristics by cohort
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 9.04 • n=8 Participants
|
62.8 years
STANDARD_DEVIATION 3.20 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 6.78 • n=16 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Height
|
160.84 centimetres
STANDARD_DEVIATION 9.548 • n=8 Participants
|
164.70 centimetres
STANDARD_DEVIATION 10.081 • n=8 Participants
|
162.77 centimetres
STANDARD_DEVIATION 9.693 • n=16 Participants
|
|
Weight
|
72.25 kg
STANDARD_DEVIATION 11.651 • n=8 Participants
|
70.75 kg
STANDARD_DEVIATION 7.506 • n=8 Participants
|
71.50 kg
STANDARD_DEVIATION 9.499 • n=16 Participants
|
|
Body Mass Index
|
27.79 kg/m^2
STANDARD_DEVIATION 2.200 • n=8 Participants
|
26.24 kg/m^2
STANDARD_DEVIATION 3.348 • n=8 Participants
|
27.01 kg/m^2
STANDARD_DEVIATION 2.851 • n=16 Participants
|
|
Child-Pugh Score
|
7.5 Child-Pugh Score has no units
STANDARD_DEVIATION 0.76 • n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
—
|
7.5 Child-Pugh Score has no units
STANDARD_DEVIATION 0.76 • n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
|
Child Pugh Score n
Child-Pugh Score 7
|
5 Participants
n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
0 Participants
Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
5 Participants
n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
|
Child Pugh Score n
Child-Pugh Score 8
|
2 Participants
n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
0 Participants
Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
2 Participants
n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
|
Child Pugh Score n
Child-Pugh Score 9
|
1 Participants
n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
0 Participants
Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
1 Participants
n=8 Participants • Child-Pugh Scoring was not performed for Cohort 2 (Subjects with Normal Hepatic Function).
|
PRIMARY outcome
Timeframe: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 onlyPopulation: In case of missing observations, the 'Number of Participants Analyzed' represents the number of non-missing observations.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097730 - AUC(0-12) Day 1
|
1000 ng.h/mL
Geometric Coefficient of Variation 22.0
|
620 ng.h/mL
Geometric Coefficient of Variation 32.7
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097730 - AUC(0-12) Day 6
|
963 ng.h/mL
Geometric Coefficient of Variation 27.4
|
634 ng.h/mL
Geometric Coefficient of Variation 20.8
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097558 - AUC(0-last) Day 6
|
12800 ng.h/mL
Geometric Coefficient of Variation 23.5
|
11400 ng.h/mL
Geometric Coefficient of Variation 33.4
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097558 - AUC(0-last) Day 6
|
1120 ng.h/mL
Geometric Coefficient of Variation 41.3
|
593 ng.h/mL
Geometric Coefficient of Variation 35.5
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097730 - AUC(0-last) Day 6
|
3300 ng.h/mL
Geometric Coefficient of Variation 25.8
|
2890 ng.h/mL
Geometric Coefficient of Variation 23.2
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097730 - AUC(0-last) Day 6
|
991 ng.h/mL
Geometric Coefficient of Variation 29.0
|
619 ng.h/mL
Geometric Coefficient of Variation 23.8
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097730 - AUC(0-12) Day 1
|
2700 ng.h/mL
Geometric Coefficient of Variation 29.8
|
1620 ng.h/mL
Geometric Coefficient of Variation 158
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097730 - AUC(0-12) Day 6
|
2640 ng.h/mL
Geometric Coefficient of Variation 21.7
|
2460 ng.h/mL
Geometric Coefficient of Variation 21.1
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097558 - AUC(0-12) Day 6
|
11600 ng.h/mL
Geometric Coefficient of Variation 20.8
|
10600 ng.h/mL
Geometric Coefficient of Variation 31.4
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097558 - AUC(0-12) Day 1
|
1240 ng.h/mL
Geometric Coefficient of Variation 28.2
|
628 ng.h/mL
Geometric Coefficient of Variation 48.8
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097558 - AUC(0-12) Day 6
|
1130 ng.h/mL
Geometric Coefficient of Variation 39.9
|
648 ng.h/mL
Geometric Coefficient of Variation 30.4
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097558 - AUC(0-12) Day 1
|
12700 ng.h/mL
Geometric Coefficient of Variation 35.1
|
7620 ng.h/mL
Geometric Coefficient of Variation 144
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6Population: In case of missing observations, the 'Number of Participants Analyzed' represents the number of non-missing observations.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097558 - Tmax Day 1
|
2.00 hours
Interval 0.5 to 3.0
|
2.00 hours
Interval 1.0 to 3.0
|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097558 - Tmax Day 6
|
2.00 hours
Interval 0.5 to 3.0
|
2.00 hours
Interval 0.5 to 4.0
|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097730 - Tmax Day 1
|
2.5 hours
Interval 1.0 to 3.0
|
2.00 hours
Interval 2.0 to 4.0
|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097730 - Tmax Day 6
|
2.50 hours
Interval 1.0 to 4.0
|
3.00 hours
Interval 1.0 to 4.0
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6Population: In case of missing observations, the 'Number of Participants Analyzed' represents the number of non-missing observations.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097558 - Cmax Day 1
|
3000 ng/mL
Geometric Coefficient of Variation 39.4
|
1800 ng/mL
Geometric Coefficient of Variation 135.0
|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097558 - Cmax Day 6
|
2570 ng/mL
Geometric Coefficient of Variation 35.5
|
2450 ng/mL
Geometric Coefficient of Variation 40.2
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097558 - Cmax Day 1
|
343 ng/mL
Geometric Coefficient of Variation 19.2
|
161 ng/mL
Geometric Coefficient of Variation 39.0
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097558 - Cmax Day 6
|
291 ng/mL
Geometric Coefficient of Variation 47.1
|
154 ng/mL
Geometric Coefficient of Variation 32.9
|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097730 - Cmax Day 1
|
471 ng/mL
Geometric Coefficient of Variation 33.3
|
299 ng/mL
Geometric Coefficient of Variation 159
|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097730 - Cmax Day 6
|
441 ng/mL
Geometric Coefficient of Variation 28.4
|
448 ng/mL
Geometric Coefficient of Variation 33.8
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097730 - Cmax Day 1
|
194 ng/mL
Geometric Coefficient of Variation 22.1
|
128 ng/mL
Geometric Coefficient of Variation 23.8
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097730 - Cmax Day 6
|
179 ng/mL
Geometric Coefficient of Variation 25.1
|
128 ng/mL
Geometric Coefficient of Variation 27.0
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 onlyPopulation: In case of missing observations, the 'Number of Participants Analyzed' represents the number of non-missing observations.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Minimum Plasma Concentration [Cmin]
Total ALG-097558 - Cmin Day 6
|
126 ng/mL
Geometric Coefficient of Variation 56.4
|
99.0 ng/mL
Geometric Coefficient of Variation 66.9
|
|
Minimum Plasma Concentration [Cmin]
Total ALG-097730 - Cmin Day 6
|
55.9 ng/mL
Geometric Coefficient of Variation 45.3
|
41.8 ng/mL
Geometric Coefficient of Variation 46.2
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: In case of missing observations, the 'Number of Participants Analyzed' represents the number of non-missing observations.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 2
|
320 ng/mL
Geometric Coefficient of Variation 55.4
|
NA ng/mL
Geometric mean and geometric CV% were not calculable because at least one concentration was BLQ and imputed to zero.
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 3
|
31.7 ng/mL
Geometric Coefficient of Variation 40.5
|
14.3 ng/mL
Geometric Coefficient of Variation 41.1
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 4
|
33.8 ng/mL
Geometric Coefficient of Variation 43.6
|
18.1 ng/mL
Geometric Coefficient of Variation 23.6
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 5
|
30.5 ng/mL
Geometric Coefficient of Variation 54.4
|
15.5 ng/mL
Geometric Coefficient of Variation 27.7
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 6
|
36.2 ng/mL
Geometric Coefficient of Variation 45.7
|
19.5 ng/mL
Geometric Coefficient of Variation 31.5
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 2
|
32.0 ng/mL
Geometric Coefficient of Variation 28.1
|
16.7 ng/mL
Geometric Coefficient of Variation 43.2
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 3
|
268 ng/mL
Geometric Coefficient of Variation 50.8
|
230 ng/mL
Geometric Coefficient of Variation 63.2
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 4
|
234 ng/mL
Geometric Coefficient of Variation 69.4
|
174 ng/mL
Geometric Coefficient of Variation 36.1
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 5
|
230 ng/mL
Geometric Coefficient of Variation 89.3
|
170 ng/mL
Geometric Coefficient of Variation 46.8
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 6
|
290 ng/mL
Geometric Coefficient of Variation 65.1
|
171 ng/mL
Geometric Coefficient of Variation 40.3
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 2
|
24.1 ng/mL
Geometric Coefficient of Variation 67.7
|
11.8 ng/mL
Geometric Coefficient of Variation 47.1
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 3
|
22.5 ng/mL
Geometric Coefficient of Variation 62.7
|
11.4 ng/mL
Geometric Coefficient of Variation 33.2
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 4
|
23.3 ng/mL
Geometric Coefficient of Variation 66.2
|
11.8 ng/mL
Geometric Coefficient of Variation 23.7
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 5
|
24.3 ng/mL
Geometric Coefficient of Variation 71.5
|
9.84 ng/mL
Geometric Coefficient of Variation 4.00
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 6
|
33.9 ng/mL
Geometric Coefficient of Variation 56.4
|
13.0 ng/mL
Geometric Coefficient of Variation 29.7
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 2
|
103 ng/mL
Geometric Coefficient of Variation 24.8
|
NA ng/mL
Geometric mean and geometric CV% were not calculable because at least one concentration was BLQ and imputed to zero.
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 3
|
97.1 ng/mL
Geometric Coefficient of Variation 35.8
|
81.7 ng/mL
Geometric Coefficient of Variation 39.5
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 4
|
93.6 ng/mL
Geometric Coefficient of Variation 48.3
|
72.2 ng/mL
Geometric Coefficient of Variation 30.8
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 5
|
86.4 ng/mL
Geometric Coefficient of Variation 48.3
|
69.5 ng/mL
Geometric Coefficient of Variation 34.6
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 6
|
97.2 ng/mL
Geometric Coefficient of Variation 45.3
|
69.9 ng/mL
Geometric Coefficient of Variation 33.3
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6 onlyPopulation: In case of missing observations, the 'Number of Participants Analyzed' represents the number of non-missing observations.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Half-life [t1/2]
Total ALG-097558 - t1/2 Day 6
|
5.74 hours
Geometric Coefficient of Variation 71.6
|
6.75 hours
Geometric Coefficient of Variation 36.8
|
|
Half-life [t1/2]
Total ALG-097730 - t1/2 Day 6
|
7.50 hours
Geometric Coefficient of Variation 82.9
|
9.44 hours
Geometric Coefficient of Variation 49.1
|
SECONDARY outcome
Timeframe: Up to 20 DaysThe number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Outcome measures
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 Participants
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 Participants
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any TEAE · Safety Set - Any TEAE
|
2 participants
|
1 participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related TEAE · Safety Set - Any TEAE
|
0 participants
|
1 participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any Grade ≥3 TEAE · Safety Set - Any TEAE
|
1 participants
|
0 participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related TEAE by severity · Safety Set - Any TEAE
|
0 participants
|
1 participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related TEAE by severity Grade 2 · Safety Set - Any TEAE
|
0 participants
|
1 participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related Grade ≥3 TEAE · Safety Set - Any TEAE
|
0 participants
|
0 participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any TEAE Leading to Early Discontinuation · Safety Set - Any TEAE
|
0 participants
|
1 participants
|
Adverse Events
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Subjects With Normal Hepatic Function
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 participants at risk
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 participants at risk
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
12.5%
1/8 • Up to 20 days
|
0.00%
0/8 • Up to 20 days
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
12.5%
1/8 • Up to 20 days
|
0.00%
0/8 • Up to 20 days
|
Other adverse events
| Measure |
Subjects With Moderate Hepatic Impairment (Child-Pughs Class B)
n=8 participants at risk
Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Hepatic Function
n=8 participants at risk
Demographically matched subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Up to 20 days
|
12.5%
1/8 • Up to 20 days
|
|
Gastrointestinal disorders
Duodenitis
|
12.5%
1/8 • Up to 20 days
|
0.00%
0/8 • Up to 20 days
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
12.5%
1/8 • Up to 20 days
|
0.00%
0/8 • Up to 20 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Up to 20 days
|
0.00%
0/8 • Up to 20 days
|
|
Injury, poisoning and procedural complications
Ligament Pain
|
12.5%
1/8 • Up to 20 days
|
0.00%
0/8 • Up to 20 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must be informed and review in advance of external publication.
- Publication restrictions are in place
Restriction type: OTHER