Trial Outcomes & Findings for An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters (NCT NCT00583713)
NCT ID: NCT00583713
Last Updated: 2010-11-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1 day
Results posted on
2010-11-11
Participant Flow
Participant milestones
| Measure |
Renal Group
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label Study to Assess the Effect of BLI800 on Safety and Clinical Chemistry Parameters
Baseline characteristics by cohort
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age Continuous
|
53.8 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 6.93 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 6.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
717.0 µmol/L
Standard Deviation 270.84
|
499.5 µmol/L
Standard Deviation 165.00
|
560.2 µmol/L
Standard Deviation 152.75
|
PRIMARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Time to Maximum Concentration
|
17.5 hours
Standard Deviation 2.95
|
16.8 hours
Standard Deviation 8.16
|
14.2 hours
Standard Deviation 5.00
|
PRIMARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Terminal Half-life
|
10.16 hours
Standard Deviation 9.32
|
8.51 hours
Standard Deviation 4.57
|
5.58 hours
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Area Under the Curve for the 24-hour Dosing Interval
|
12,332.95 µmol*hr/L
Standard Deviation 4,193.54
|
8,029.88 µmol*hr/L
Standard Deviation 3,424.42
|
10,751.75 µmol*hr/L
Standard Deviation 2,878.17
|
PRIMARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Elimination Rate Constant
|
0.127 1/hr
Standard Deviation 0.09
|
0.107 1/hr
Standard Deviation 0.06
|
0.141 1/hr
Standard Deviation 0.050
|
SECONDARY outcome
Timeframe: pre-dose to 6 days post-doseOutcome measures
| Measure |
Renal Group
n=6 Participants
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 Participants
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 Participants
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Urinary Sulfate Concentration
Pre-dose 1
|
91.58 mg/dL
Standard Deviation 40.12
|
131.20 mg/dL
Standard Deviation 46.98
|
86.92 mg/dL
Standard Deviation 50.09
|
|
Urinary Sulfate Concentration
Day 3
|
135.53 mg/dL
Standard Deviation 86.28
|
145.62 mg/dL
Standard Deviation 111.02
|
89.83 mg/dL
Standard Deviation 67.81
|
|
Urinary Sulfate Concentration
Day 6
|
96.98 mg/dL
Standard Deviation 47.61
|
134.65 mg/dL
Standard Deviation 74.72
|
70.82 mg/dL
Standard Deviation 83.64
|
Adverse Events
Renal Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Hepatic Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Renal Group
n=6 participants at risk
BLI-800 oral solution in patients with moderate renal impairment
|
Healthy Volunteers
n=6 participants at risk
BLI-800 oral solution in healthy volunteers
|
Hepatic Group
n=6 participants at risk
BLI-800 oral solution in patients with mild/moderate hepatic impairment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
50.0%
3/6
|
50.0%
3/6
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6
|
0.00%
0/6
|
16.7%
1/6
|
|
General disorders
Chills
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Perianal irritation
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Abnormal urinalysis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Elevated serum creatinine
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Symptomatic hypoglycemia
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER