Trial Outcomes & Findings for Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function (NCT NCT05765344)
NCT ID: NCT05765344
Last Updated: 2026-01-26
Results Overview
AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
Day 6: Predose and up to 24 hours postdose
Results posted on
2026-01-26
Participant Flow
Participants were enrolled at study sites in the United States.
124 participants were screened.
Participant milestones
| Measure |
Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment
Participants with moderate hepatic impairment received BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Severe Hepatic Impairment
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
8
|
8
|
10
|
10
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
10
|
8
|
8
|
10
|
10
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment
Participants with moderate hepatic impairment received BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Severe Hepatic Impairment
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function
Baseline characteristics by cohort
| Measure |
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=11 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
|
7 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
8 Participants
n=140 Participants
|
8 Participants
n=58 Participants
|
7 Participants
n=12 Participants
|
61 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
2 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=12 Participants
|
13 Participants
n=12 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 7.4
|
59 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
56 years
STANDARD_DEVIATION 7.4 • n=1581 Participants
|
47 years
STANDARD_DEVIATION 12.5 • n=4626 Participants
|
46 years
STANDARD_DEVIATION 12.7 • n=72 Participants
|
59 years
STANDARD_DEVIATION 6.0 • n=140 Participants
|
52 years
STANDARD_DEVIATION 7.7 • n=58 Participants
|
53 years
STANDARD_DEVIATION 8.6 • n=12 Participants
|
55 years
STANDARD_DEVIATION 10.2 • n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
3 Participants
n=140 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=12 Participants
|
26 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
|
8 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
7 Participants
n=140 Participants
|
5 Participants
n=58 Participants
|
5 Participants
n=12 Participants
|
48 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
|
7 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
6 Participants
n=140 Participants
|
6 Participants
n=58 Participants
|
6 Participants
n=12 Participants
|
52 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
4 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
2 Participants
n=12 Participants
|
22 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
|
10 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
8 Participants
n=72 Participants
|
9 Participants
n=140 Participants
|
8 Participants
n=58 Participants
|
6 Participants
n=12 Participants
|
68 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
10 Participants
|
11 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
8 Participants
n=72 Participants
|
10 Participants
n=140 Participants
|
8 Participants
n=58 Participants
|
8 Participants
n=12 Participants
|
74 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Day 6: Predose and up to 24 hours postdosePopulation: The plasma PK Analysis Set included all enrolled participants who took at least 1 dose of BLV and had at least 1 measurable plasma PK concentration data reported by PK laboratory for the analyte BLV. Participants in the plasma PK Analysis Set with available data were analyzed.
AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=9 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=7 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=5 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
|
1520 h*ng/mL
Standard Deviation 459
|
1560 h*ng/mL
Standard Deviation 347
|
1270 h*ng/mL
Standard Deviation 776
|
152 h*ng/mL
Standard Deviation 110
|
150 h*ng/mL
Standard Deviation 66.9
|
215 h*ng/mL
Standard Deviation 71.7
|
113 h*ng/mL
Standard Deviation 45.8
|
1600 h*ng/mL
Standard Deviation 502
|
PRIMARY outcome
Timeframe: Day 6: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.
Cmax,ss was defined as the maximum observed concentration of drug at steady state.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax,ss of BLV
|
293 ng/mL
Standard Deviation 96.8
|
261 ng/mL
Standard Deviation 64.1
|
175 ng/mL
Standard Deviation 113
|
29.5 ng/mL
Standard Deviation 23.8
|
22.7 ng/mL
Standard Deviation 14.7
|
61.4 ng/mL
Standard Deviation 27.6
|
15.2 ng/mL
Standard Deviation 6.64
|
263 ng/mL
Standard Deviation 101
|
SECONDARY outcome
Timeframe: Day 1: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.
AUC0-24h was defined as the partial area under the concentration versus time curve from time zero to time 24 hours.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=9 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=7 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=6 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUC0-24h of BLV
|
1220 h*ng/mL
Standard Deviation 350
|
850 h*ng/mL
Standard Deviation 337
|
672 h*ng/mL
Standard Deviation 434
|
82.9 h*ng/mL
Standard Deviation 55.2
|
54.0 h*ng/mL
Standard Deviation 12.8
|
174 h*ng/mL
Standard Deviation 77.9
|
51.2 h*ng/mL
Standard Deviation 8.90
|
750 h*ng/mL
Standard Deviation 376
|
SECONDARY outcome
Timeframe: Days 1 and 6: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.
Tmax was defined as the time (observed time point) of Cmax.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=11 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Tmax of BLV
Day 1
|
3.00 hours
Interval 1.5 to 4.0
|
5.00 hours
Interval 2.0 to 9.0
|
4.00 hours
Interval 1.0 to 9.0
|
1.50 hours
Interval 0.5 to 3.0
|
1.48 hours
Interval 1.0 to 2.0
|
1.00 hours
Interval 0.983 to 1.5
|
1.50 hours
Interval 1.0 to 2.03
|
5.00 hours
Interval 1.5 to 9.0
|
|
PK Parameter: Tmax of BLV
Day 6
|
2.50 hours
Interval 2.0 to 3.0
|
3.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 3.0 to 6.0
|
1.38 hours
Interval 0.5 to 1.6
|
1.51 hours
Interval 1.03 to 3.0
|
1.02 hours
Interval 1.0 to 1.5
|
1.75 hours
Interval 1.0 to 3.0
|
3.00 hours
Interval 2.97 to 4.0
|
SECONDARY outcome
Timeframe: Day 1: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set were analyzed.
Cmax was defined as the maximum observed plasma concentration of drug.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=11 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of BLV
|
230 ng/mL
Standard Deviation 85.4
|
127 ng/mL
Standard Deviation 65.6
|
99.2 ng/mL
Standard Deviation 94.3
|
23.7 ng/mL
Standard Deviation 15.2
|
12.6 ng/mL
Standard Deviation 4.28
|
57.7 ng/mL
Standard Deviation 24.2
|
12.4 ng/mL
Standard Deviation 3.84
|
103 ng/mL
Standard Deviation 69.6
|
SECONDARY outcome
Timeframe: Day 6: Predose and up to 48 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.
t1/2 was defined as estimate of the terminal elimination half-life of the drug in plasma, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz).
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=7 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: t1/2 of BLV
|
2.78 hours
Standard Deviation 0.750
|
2.80 hours
Standard Deviation 0.795
|
3.49 hours
Standard Deviation 1.15
|
3.34 hours
Standard Deviation 1.31
|
2.86 hours
Standard Deviation 0.686
|
2.31 hours
Standard Deviation 0.791
|
5.05 hours
Standard Deviation 2.39
|
3.33 hours
Standard Deviation 0.975
|
SECONDARY outcome
Timeframe: Day 6: Predose and up to 48 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.
CLss/F was defined as the apparent clearance at the steady state (CLss) after administration of the drug: CLss/F = Dose/AUCtau, where "Dose" is the dose of the drug per interval.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=7 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: CLss/F of BLV
|
7.06 L/h
Standard Deviation 1.98
|
6.70 L/h
Standard Deviation 1.62
|
9.63 L/h
Standard Deviation 3.88
|
22.1 L/h
Standard Deviation 13.9
|
15.8 L/h
Standard Deviation 7.21
|
9.97 L/h
Standard Deviation 2.46
|
19.8 L/h
Standard Deviation 7.20
|
6.76 L/h
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Day 6: Predose and up to 48 hours postdosePopulation: Participants in the Plasma BLV PK Analysis Set with available data were analyzed.
Vss/F was defined as the apparent steady-state volume of distribution of the drug.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=7 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Vss/F of BLV
|
28.4 liters
Standard Deviation 11.9
|
27.8 liters
Standard Deviation 13.9
|
52.6 liters
Standard Deviation 33.5
|
119 liters
Standard Deviation 100
|
70.7 liters
Standard Deviation 46.3
|
34.4 liters
Standard Deviation 16.1
|
148 liters
Standard Deviation 78.8
|
34.5 liters
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Predose on Days 2, 3, 4, 5, 7, and 8Population: The plasma pharmacodynamic (PD) Analysis Set included all enrolled participants who received at least 1 dose of study drug BLV and had at least 1 measurable plasma PD concentration value reported for the analyte BA. Participants in the Plasma BA PD Analysis Set with available data were analyzed.
Ctrough was defined as the concentration of total BA at the end of the dosing interval.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Day 2
|
158 uM
Standard Deviation 60.5
|
25.7 uM
Standard Deviation 19.6
|
50.6 uM
Standard Deviation 55.1
|
26.5 uM
Standard Deviation 27.1
|
4.68 uM
Standard Deviation 3.06
|
223 uM
Standard Deviation 131
|
5.18 uM
Standard Deviation 4.79
|
31.0 uM
Standard Deviation 25.5
|
|
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Day 3
|
180 uM
Standard Deviation 69.4
|
22.6 uM
Standard Deviation 9.53
|
67.2 uM
Standard Deviation 70.9
|
46.3 uM
Standard Deviation 49.7
|
7.96 uM
Standard Deviation 7.00
|
213 uM
Standard Deviation 132
|
6.60 uM
Standard Deviation 2.74
|
29.5 uM
Standard Deviation 25.1
|
|
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Day 4
|
157 uM
Standard Deviation 87.1
|
23.3 uM
Standard Deviation 14.8
|
57.3 uM
Standard Deviation 46.0
|
41.9 uM
Standard Deviation 50.5
|
6.86 uM
Standard Deviation 3.58
|
192 uM
Standard Deviation 121
|
6.03 uM
Standard Deviation 5.32
|
16.1 uM
Standard Deviation 8.68
|
|
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Day 5
|
176 uM
Standard Deviation 96.1
|
25.1 uM
Standard Deviation 12.2
|
50.6 uM
Standard Deviation 26.2
|
30.5 uM
Standard Deviation 23.3
|
7.65 uM
Standard Deviation 3.85
|
201 uM
Standard Deviation 119
|
7.96 uM
Standard Deviation 6.01
|
23.7 uM
Standard Deviation 13.9
|
|
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Day 7
|
222 uM
Standard Deviation 97.0
|
21.8 uM
Standard Deviation 13.7
|
80.7 uM
Standard Deviation 65.9
|
38.2 uM
Standard Deviation 37.3
|
10.2 uM
Standard Deviation 5.55
|
170 uM
Standard Deviation 91.3
|
8.44 uM
Standard Deviation 7.68
|
25.9 uM
Standard Deviation 16.0
|
|
Pharmacodynamic (PD) Parameter: Ctrough of Total Bile Acids (BA)
Day 8
|
129 uM
Standard Deviation 78.9
|
7.29 uM
Standard Deviation 3.73
|
37.1 uM
Standard Deviation 53.1
|
33.4 uM
Standard Deviation 37.4
|
6.76 uM
Standard Deviation 5.62
|
151 uM
Standard Deviation 82.0
|
5.69 uM
Standard Deviation 3.73
|
11.0 uM
Standard Deviation 9.21
|
SECONDARY outcome
Timeframe: Days 1 and 6: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BA PD Analysis Set with available data were analyzed.
Cmax was defined as the maximum observed concentration of total BA.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=9 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PD Parameter: Cmax of Total BA
Day 6
|
370 uM
Standard Deviation 51.7
|
180 uM
Standard Deviation 35.8
|
343 uM
Standard Deviation 134
|
124 uM
Standard Deviation 117
|
85.5 uM
Standard Deviation 42.2
|
318 uM
Standard Deviation 97.9
|
62.9 uM
Standard Deviation 44.6
|
221 uM
Standard Deviation 78.9
|
|
PD Parameter: Cmax of Total BA
Day 1
|
305 uM
Standard Deviation 40.9
|
145 uM
Standard Deviation 44.5
|
176 uM
Standard Deviation 99.7
|
46.6 uM
Standard Deviation 61.4
|
15.6 uM
Standard Deviation 15.4
|
317 uM
Standard Deviation 156
|
13.1 uM
Standard Deviation 4.30
|
150 uM
Standard Deviation 72.0
|
SECONDARY outcome
Timeframe: Days 1 and 6: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BA PD Analysis Set with available data were analyzed.
AUC0-24 was defined as the partial area under the concentration versus time curve from time "0" to time "24" hours for total BA.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=9 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PD Parameter: AUC0-24h of Total BA
Day 6
|
6840 uM*h
Standard Deviation 1250
|
2330 uM*h
Standard Deviation 527
|
4640 uM*h
Standard Deviation 2010
|
1840 uM*h
Standard Deviation 1790
|
1000 uM*h
Standard Deviation 391
|
5680 uM*h
Standard Deviation 2010
|
720 uM*h
Standard Deviation 472
|
2920 uM*h
Standard Deviation 1150
|
|
PD Parameter: AUC0-24h of Total BA
Day 1
|
5130 uM*h
Standard Deviation 918
|
1690 uM*h
Standard Deviation 348
|
2270 uM*h
Standard Deviation 1440
|
766 uM*h
Standard Deviation 1010
|
195 uM*h
Standard Deviation 174
|
5870 uM*h
Standard Deviation 2930
|
168 uM*h
Standard Deviation 69.5
|
1760 uM*h
Standard Deviation 748
|
SECONDARY outcome
Timeframe: Days 1 and 6: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BA PD Analysis Set with available data were analyzed.
NetAUC was defined as the positive portion of area under the baseline-adjusted biomarker concentration versus time curve over the dosing interval.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=9 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PD Parameter: NetAUC of Total BA
Day 6
|
4030 uM*h
Standard Deviation 1220
|
2270 uM*h
Standard Deviation 542
|
4210 uM*h
Standard Deviation 1410
|
768 uM*h
Standard Deviation 773
|
925 uM*h
Standard Deviation 392
|
1880 uM*h
Standard Deviation 1120
|
657 uM*h
Standard Deviation 467
|
2850 uM*h
Standard Deviation 1140
|
|
PD Parameter: NetAUC of Total BA
Day 1
|
2380 uM*h
Standard Deviation 781
|
1630 uM*h
Standard Deviation 334
|
1880 uM*h
Standard Deviation 1020
|
259 uM*h
Standard Deviation 345
|
133 uM*h
Standard Deviation 154
|
1790 uM*h
Standard Deviation 1430
|
113 uM*h
Standard Deviation 66.9
|
1690 uM*h
Standard Deviation 731
|
SECONDARY outcome
Timeframe: Days 1 and 6: Predose and up to 24 hours postdosePopulation: Participants in the Plasma BA PD Analysis Set with available data were analyzed.
Tmax was defined as the time (observed time point) of Cmax of total BA.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=9 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
PD Parameter: Tmax of Total BA
Day 1
|
12.0 hours
Interval 6.0 to 12.0
|
10.5 hours
Interval 6.0 to 12.1
|
12.0 hours
Interval 6.0 to 12.0
|
9.08 hours
Interval -0.5 to 12.0
|
9.00 hours
Interval 6.0 to 23.5
|
7.50 hours
Interval 4.0 to 12.0
|
12.0 hours
Interval 6.0 to 24.7
|
10.6 hours
Interval 9.0 to 12.0
|
|
PD Parameter: Tmax of Total BA
Day 6
|
12.0 hours
Interval 6.0 to 12.1
|
9.00 hours
Interval 3.0 to 12.0
|
12.0 hours
Interval 6.0 to 12.0
|
6.02 hours
Interval 1.5 to 12.0
|
9.00 hours
Interval 6.0 to 12.0
|
7.50 hours
Interval 6.0 to 12.0
|
10.5 hours
Interval 4.0 to 12.1
|
10.5 hours
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: First dose date up to Day 6 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug. If the AE onset date is the same as the date of study drug start date then the AE onset time must be on or after the study drug start time. If the AE onset time is missing when the start dates were the same, the AE were considered treatment emergent. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=11 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
25.0 percentage of participants
|
20.0 percentage of participants
|
20.0 percentage of participants
|
27.3 percentage of participants
|
9.1 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 6 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment emergent. Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening; Grade 5: Death.
Outcome measures
| Measure |
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 Participants
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 Participants
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=11 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 Participants
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 Participants
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Laboratory Abnormalities
Any Grade 1 or Higher
|
75.0 percentage of participants
|
90.0 percentage of participants
|
90.0 percentage of participants
|
63.6 percentage of participants
|
63.6 percentage of participants
|
100.0 percentage of participants
|
62.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Laboratory Abnormalities
Grade 3 or 4
|
25.0 percentage of participants
|
0.0 percentage of participants
|
10.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Group A: BLV 2 mg, Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group A: BLV 2 mg, Matched Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: BLV 2 mg, Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group B: BLV 2 mg, Matched Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group C: BLV 10 mg, Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group C: BLV 10 mg, Matched Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group D: BLV 10 mg, Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group D: BLV 10 mg, Matched Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: BLV 2 mg, Moderate Hepatic Impairment
n=11 participants at risk
Participants with moderate hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group A: BLV 2 mg, Matched Control
n=11 participants at risk
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Severe Hepatic Impairment
n=8 participants at risk
Participants with severe hepatic impairment received BLV 2 mg SC injection, once daily for 6 days starting on Day 1.
|
Group B: BLV 2 mg, Matched Control
n=8 participants at risk
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 2 mg SC injection once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Moderate Hepatic Impairment
n=10 participants at risk
Participants with moderate hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group C: BLV 10 mg, Matched Control
n=10 participants at risk
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Severe Hepatic Impairment
n=8 participants at risk
Participants with severe hepatic impairment received BLV 10 mg SC injection, once daily for 6 days starting on Day 1.
|
Group D: BLV 10 mg, Matched Control
n=8 participants at risk
Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants received BLV 10 mg SC injection once daily for 6 days starting on Day 1.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
General disorders
Injection site reaction
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
9.1%
1/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
20.0%
2/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Lipase increased
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
10.0%
1/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Investigations
Transaminases increased
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
12.5%
1/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/11 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/10 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
0.00%
0/8 • Up to Day 6 plus 30 days
All-cause Mortality: The All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening. Adverse Events: The Safety Analysis Set included all participants who took at least 1 dose of study drug BLV.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER