Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function (NCT NCT06698549)
NCT ID: NCT06698549
Last Updated: 2026-07-09
Results Overview
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Pre-dose (-0.75 hours) up to Day 8
Results posted on
2026-07-09
Participant Flow
Participants were recruited at 3 investigational sites. The first participant enrolled was on 20-Feb-2025 and the last participant was enrolled on 15-Jul-2025.
For Part 1, 12 participants were enrolled in the study, and all participants received the study drug. Part 2 (including optional cohorts: Subjects with Mild Renal Impairment and Subjects with Moderate Renal Impairment) was not conducted based on the Part 1 results not meeting the protocol defined criteria.
Participant milestones
| Measure |
Subjects With Severe Renal Impairment
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Overall Study
STARTED
|
6
|
6
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Subjects With Severe Renal Impairment
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
Baseline characteristics by cohort
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 14.01 • n=20 Participants
|
47.3 years
STANDARD_DEVIATION 6.38 • n=20 Participants
|
—
|
—
|
50.3 years
STANDARD_DEVIATION 10.84 • n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
1 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
2 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
5 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
10 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
2 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
5 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
eGFR BSA adjusted
|
16.75 mL/min
STANDARD_DEVIATION 7.998 • n=20 Participants
|
124.00 mL/min
STANDARD_DEVIATION 14.782 • n=20 Participants
|
—
|
—
|
70.38 mL/min
STANDARD_DEVIATION 57.144 • n=9 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
4 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
7 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
4 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
9 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
2 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
3 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=20 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=40 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=5 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
0 Participants
n=9 Participants • Part 2 of the trial which included optional arms was not conducted based on the Part 1 results not meeting the protocol-defined criterion of ≥2-fold change of ALG-097558 total exposure (i.e., AUC) required to trigger Part 2.
|
|
Region of Enrollment
United States
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
—
|
—
|
12 Participants
n=9 Participants
|
|
Height
|
171.18 centimetres
STANDARD_DEVIATION 9.839 • n=20 Participants
|
175.62 centimetres
STANDARD_DEVIATION 7.612 • n=20 Participants
|
—
|
—
|
173.40 centimetres
STANDARD_DEVIATION 8.701 • n=9 Participants
|
|
Weight
|
80.47 kg
STANDARD_DEVIATION 23.584 • n=20 Participants
|
77.08 kg
STANDARD_DEVIATION 7.184 • n=20 Participants
|
—
|
—
|
78.78 kg
STANDARD_DEVIATION 16.715 • n=9 Participants
|
|
Body Mass Index
|
27.20 kg/m^2
STANDARD_DEVIATION 6.073 • n=20 Participants
|
24.95 kg/m^2
STANDARD_DEVIATION 0.517 • n=20 Participants
|
—
|
—
|
26.08 kg/m^2
STANDARD_DEVIATION 4.274 • n=9 Participants
|
|
Baseline eGFR
|
16.83 (mL/min)/1.73 m^2
STANDARD_DEVIATION 9.174 • n=20 Participants
|
114.50 (mL/min)/1.73 m^2
STANDARD_DEVIATION 10.784 • n=20 Participants
|
—
|
—
|
65.67 (mL/min)/1.73 m^2
STANDARD_DEVIATION 51.890 • n=9 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 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-097558 - AUC0-last Day 6
|
867 ng.h/mL
Geometric Coefficient of Variation 50.3
|
568 ng.h/mL
Geometric Coefficient of Variation 39.7
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097730 - AUC0-last Day 6
|
7400 ng.h/mL
Geometric Coefficient of Variation 70.3
|
4300 ng.h/mL
Geometric Coefficient of Variation 24.5
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097730 - AUC0-last Day 6
|
1020 ng.h/mL
Geometric Coefficient of Variation 68.8
|
620 ng.h/mL
Geometric Coefficient of Variation 42.9
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097558 - AUC0-last Day 6
|
23900 ng.h/mL
Geometric Coefficient of Variation 54.5
|
15700 ng.h/mL
Geometric Coefficient of Variation 35.5
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097558 - AUC0-12 Day 1
|
27000 ng.h/mL
Geometric Coefficient of Variation 71.6
|
14300 ng.h/mL
Geometric Coefficient of Variation 34.4
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097558 - AUC0-12 Day 6
|
21100 ng.h/mL
Geometric Coefficient of Variation 53.0
|
14300 ng.h/mL
Geometric Coefficient of Variation 35.5
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097558 - AUC0-12 Day 1
|
1070 ng.h/mL
Geometric Coefficient of Variation 74.7
|
561 ng.h/mL
Geometric Coefficient of Variation 58.0
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097558 - AUC0-12 Day 6
|
857 ng.h/mL
Geometric Coefficient of Variation 50.1
|
694 ng.h/mL
Geometric Coefficient of Variation 25.8
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097730 - AUC0-12 Day 1
|
6040 ng.h/mL
Geometric Coefficient of Variation 65.7
|
3260 ng.h/mL
Geometric Coefficient of Variation 28.4
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Total ALG-097730 - AUC0-12 Day 6
|
5650 ng.h/mL
Geometric Coefficient of Variation 62.3
|
3490 ng.h/mL
Geometric Coefficient of Variation 28.2
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097730 - AUC0-12 Day 1
|
1130 ng.h/mL
Geometric Coefficient of Variation 73.0
|
630 ng.h/mL
Geometric Coefficient of Variation 54.2
|
—
|
—
|
|
Area Under the Concentration Time Curve [AUC]
Unbound ALG-097730 - AUC0-12 Day 6
|
992 ng.h/mL
Geometric Coefficient of Variation 67.1
|
620 ng.h/mL
Geometric Coefficient of Variation 43.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 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
|
5260 ng/mL
Geometric Coefficient of Variation 55.8
|
3500 ng/mL
Geometric Coefficient of Variation 35.7
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097558 - Cmax Day 6
|
3870 ng/mL
Geometric Coefficient of Variation 38.6
|
3040 ng/mL
Geometric Coefficient of Variation 45.0
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097558 - Cmax Day 1
|
252 ng/mL
Geometric Coefficient of Variation 58.3
|
182 ng/mL
Geometric Coefficient of Variation 50.9
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097558 - Cmax Day 6
|
178 ng/mL
Geometric Coefficient of Variation 44.7
|
147 ng/mL
Geometric Coefficient of Variation 47.7
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097730 - Cmax Day 1
|
893 ng/mL
Geometric Coefficient of Variation 45.8
|
611 ng/mL
Geometric Coefficient of Variation 31.9
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Total ALG-097730 - Cmax Day 6
|
853 ng/mL
Geometric Coefficient of Variation 46.5
|
584 ng/mL
Geometric Coefficient of Variation 36.8
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097730 - Cmax Day 1
|
194 ng/mL
Geometric Coefficient of Variation 49.1
|
144 ng/mL
Geometric Coefficient of Variation 49.8
|
—
|
—
|
|
Maximum Plasma Concentration [Cmax]
Unbound ALG-097730 - Cmax Day 6
|
179 ng/mL
Geometric Coefficient of Variation 47.1
|
123 ng/mL
Geometric Coefficient of Variation 59.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 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
|
326 ng/mL
Geometric Coefficient of Variation 108
|
160 ng/mL
Geometric Coefficient of Variation 38.0
|
—
|
—
|
|
Minimum Plasma Concentration [Cmin]
Total ALG-097730 - Cmin Day 6
|
154 ng/mL
Geometric Coefficient of Variation 100
|
75.0 ng/mL
Geometric Coefficient of Variation 35.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 2
|
509 ng/mL
Geometric Coefficient of Variation 122
|
226 ng/mL
Geometric Coefficient of Variation 30.7
|
—
|
—
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 3
|
464 ng/mL
Geometric Coefficient of Variation 59.5
|
323 ng/mL
Geometric Coefficient of Variation 44.3
|
—
|
—
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 4
|
542 ng/mL
Geometric Coefficient of Variation 89.4
|
372 ng/mL
Geometric Coefficient of Variation 46.4
|
—
|
—
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 5
|
424 ng/mL
Geometric Coefficient of Variation 67.5
|
295 ng/mL
Geometric Coefficient of Variation 108
|
—
|
—
|
|
C0 [Predose]
Total ALG-097558 - Ctrough Day 6
|
623 ng/mL
Geometric Coefficient of Variation 66.6
|
321 ng/mL
Geometric Coefficient of Variation 58.3
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 2
|
29.4 ng/mL
Geometric Coefficient of Variation 69.7
|
NA ng/mL
Geometric mean and geometric CV% has be set to "n/a" as there was only one reportable value at this timepoint
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 3
|
15.0 ng/mL
Geometric Coefficient of Variation 67.0
|
11.7 ng/mL
Geometric Coefficient of Variation 4.55
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 4
|
20.9 ng/mL
Geometric Coefficient of Variation 61.6
|
13.5 ng/mL
Geometric Coefficient of Variation 14.3
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 5
|
14.8 ng/mL
Geometric Coefficient of Variation 72.2
|
14.8 ng/mL
Geometric Coefficient of Variation 35.9
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097558 - Ctrough Day 6
|
19.1 ng/mL
Geometric Coefficient of Variation 68.1
|
13.7 ng/mL
Geometric Coefficient of Variation 44.2
|
—
|
—
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 2
|
218 ng/mL
Geometric Coefficient of Variation 129
|
100 ng/mL
Geometric Coefficient of Variation 25.3
|
—
|
—
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 3
|
205 ng/mL
Geometric Coefficient of Variation 71.2
|
119 ng/mL
Geometric Coefficient of Variation 38.4
|
—
|
—
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 4
|
226 ng/mL
Geometric Coefficient of Variation 89.1
|
135 ng/mL
Geometric Coefficient of Variation 33.9
|
—
|
—
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 5
|
198 ng/mL
Geometric Coefficient of Variation 84.1
|
114 ng/mL
Geometric Coefficient of Variation 66.7
|
—
|
—
|
|
C0 [Predose]
Total ALG-097730 - Ctrough Day 6
|
249 ng/mL
Geometric Coefficient of Variation 75.6
|
120 ng/mL
Geometric Coefficient of Variation 44.2
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 2
|
28.1 ng/mL
Geometric Coefficient of Variation 149
|
13.7 ng/mL
Geometric Coefficient of Variation 48.9
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 3
|
28.3 ng/mL
Geometric Coefficient of Variation 101
|
16.7 ng/mL
Geometric Coefficient of Variation 18.5
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 4
|
29.3 ng/mL
Geometric Coefficient of Variation 103
|
18.8 ng/mL
Geometric Coefficient of Variation 30.8
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 5
|
26.0 ng/mL
Geometric Coefficient of Variation 102
|
17.1 ng/mL
Geometric Coefficient of Variation 56.2
|
—
|
—
|
|
C0 [Predose]
Unbound ALG-097730 - Ctrough Day 6
|
37.7 ng/mL
Geometric Coefficient of Variation 85.0
|
18.2 ng/mL
Geometric Coefficient of Variation 57.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 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
|
8.80 hours
Geometric Coefficient of Variation 32.3
|
7.29 hours
Geometric Coefficient of Variation 39.0
|
—
|
—
|
|
Half-life [t1/2]
Total ALG-097730 - t1/2 Day 6
|
11.4 hours
Geometric Coefficient of Variation 40.5
|
11.6 hours
Geometric Coefficient of Variation 48.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 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 1.92 to 3.67
|
2.02 hours
Interval 2.0 to 3.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097558 - Tmax Day 6
|
3.00 hours
Interval 2.0 to 4.05
|
2.50 hours
Interval 1.0 to 6.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097730 - Tmax Day 1
|
3.83 hours
Interval 2.0 to 6.0
|
3.00 hours
Interval 2.0 to 3.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration [Tmax]
Total ALG-097730 - Tmax Day 6
|
3.49 hours
Interval 3.0 to 8.02
|
2.00 hours
Interval 1.0 to 3.02
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F)
Total ALG-097558 - CL/F Day 6
|
14.3 L/h
Geometric Coefficient of Variation 53.0
|
21.0 L/h
Geometric Coefficient of Variation 35.5
|
—
|
—
|
|
Apparent Clearance (CL/F)
Unbound ALG-097558 - CL/F Day 6
|
350 L/h
Geometric Coefficient of Variation 50.1
|
432 L/h
Geometric Coefficient of Variation 25.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (V/F)
Total ALG-097558 - Vz/F Day 6
|
181 L
Geometric Coefficient of Variation 68.1
|
220 L
Geometric Coefficient of Variation 49.1
|
—
|
—
|
|
Apparent Volume of Distribution (V/F)
Unbound ALG-097558 - Vz/F Day 6
|
1300 L
Geometric Coefficient of Variation 97.3
|
1450 L
Geometric Coefficient of Variation 21.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-6 Day 1
|
2.10 mg
Standard Deviation 0.736
|
10.8 mg
Standard Deviation 5.86
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 6-12 Day 1
|
0.979 mg
Standard Deviation 0.665
|
1.24 mg
Standard Deviation 1.37
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-12 Day 1
|
3.08 mg
Standard Deviation 1.23
|
12.1 mg
Standard Deviation 6.61
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-6 Day 6
|
1.46 mg
Standard Deviation 0.750
|
8.03 mg
Standard Deviation 5.95
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 6-12 Day 6
|
0.708 mg
Standard Deviation 0.600
|
1.04 mg
Standard Deviation 0.641
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 12-24 Day 6
|
0.182 mg
Standard Deviation 0.157
|
0.249 mg
Standard Deviation 0.0620
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 24-36 Day 6
|
0.0348 mg
Standard Deviation 0.0168
|
0.0817 mg
Standard Deviation 0.0446
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 36-48 Day 6
|
0.0113 mg
Standard Deviation 0.00526
|
0.0386 mg
Standard Deviation 0.0284
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-12 Day 6
|
2.16 mg
Standard Deviation 0.916
|
9.06 mg
Standard Deviation 6.54
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-24 Day 6
|
2.35 mg
Standard Deviation 0.966
|
9.31 mg
Standard Deviation 6.56
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-36 Day 6
|
2.38 mg
Standard Deviation 0.973
|
9.39 mg
Standard Deviation 6.57
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097558 - Ae 0-48 Day 6
|
2.39 mg
Standard Deviation 0.975
|
9.43 mg
Standard Deviation 6.56
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-6 Day 1
|
0.615 mg
Standard Deviation 0.174
|
3.44 mg
Standard Deviation 1.69
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 6-12 Day 1
|
0.479 mg
Standard Deviation 0.299
|
0.701 mg
Standard Deviation 0.676
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-12 Day 1
|
1.09 mg
Standard Deviation 0.274
|
4.14 mg
Standard Deviation 2.00
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-6 Day 6
|
0.651 mg
Standard Deviation 0.323
|
2.81 mg
Standard Deviation 1.65
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 6-12 Day 6
|
0.467 mg
Standard Deviation 0.469
|
0.733 mg
Standard Deviation 0.452
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 12-24 Day 6
|
0.181 mg
Standard Deviation 0.220
|
0.260 mg
Standard Deviation 0.0772
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 24-36 Day 6
|
0.0602 mg
Standard Deviation 0.0619
|
0.109 mg
Standard Deviation 0.0369
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 36-48 Day 6
|
0.0255 mg
Standard Deviation 0.0203
|
0.0660 mg
Standard Deviation 0.0494
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-12 Day 6
|
1.12 mg
Standard Deviation 0.677
|
3.54 mg
Standard Deviation 2.08
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-24 Day 6
|
1.30 mg
Standard Deviation 0.858
|
3.80 mg
Standard Deviation 2.13
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-36 Day 6
|
1.36 mg
Standard Deviation 0.917
|
3.91 mg
Standard Deviation 2.16
|
—
|
—
|
|
Total Amount of Drug Excreted in Urine (Ae)
Total ALG-097730 - Ae 0-48 Day 6
|
1.38 mg
Standard Deviation 0.933
|
3.98 mg
Standard Deviation 2.14
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (-0.75 hours) up to Day 8Population: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Renal Clearance (CLr)
Total ALG-097558 - CLr Day 6
|
0.102 L/h
Standard Deviation 0.0447
|
0.666 L/h
Standard Deviation 0.539
|
—
|
—
|
|
Renal Clearance (CLr)
Total ALG-097730 - CLr Day 6
|
0.181 L/h
Standard Deviation 0.0753
|
1.04 L/h
Standard Deviation 0.694
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 DaysPopulation: The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 (July 2017)
Outcome measures
| Measure |
Subjects With Severe Renal Impairment
n=6 Participants
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 Participants
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 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
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related TEAE
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any grade ≥3 TEAE
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related grade ≥3 TEAE
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any SAE
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any treatment-related SAE
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any TEAE leading to early discontinuation
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any death
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
Adverse Events
Subjects With Severe Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Subjects With Normal Renal Function
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Subjects With Mild Renal Impairment (Optional)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects With Moderate Renal Impairment (Optional)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects With Severe Renal Impairment
n=6 participants at risk
Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Normal Renal Function
n=6 participants at risk
Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Mild Renal Impairment (Optional)
Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
Subjects With Moderate Renal Impairment (Optional)
Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
16.7%
1/6 • Number of events 1 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
—
0/0 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
—
0/0 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
0.00%
0/6 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
—
0/0 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
—
0/0 • Up to 20 days
The number of participants for the optional cohorts is 0 because Part 2 (including the optional cohorts) was not conducted based on the Part 1 results not meeting the protocol-defined criterion to trigger part 2.
|
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