Trial Outcomes & Findings for Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF (NCT NCT01937130)
NCT ID: NCT01937130
Last Updated: 2016-04-11
Results Overview
Primary endpoints for AUC\_0-8, AUC\_0 last, AUC\_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
28 days
Results posted on
2016-04-11
Participant Flow
In total, 33 subjects were screened at 14 sites, and 23 subjects were randomized to one of the 4 treatment arms.
23 subjects were randomized but 21 subjects received treatment. 1 subject lost due to death and 1 subject lost due to withdrew of consent. 7 subject of 21 completed the treatment phase (Day 28). 4 of 3 completed the two follow-up phone calls made at Months 3 and 6. 14 subjects discontinued the study early.
Participant milestones
| Measure |
IDN-6556 5 mg
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
Dosed twice daily
IDN-6556
|
Placebo
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
IDN-6556 5 mg
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
Dosed twice daily
IDN-6556
|
Placebo
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Patients unable to swallow
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient lost to FU due to death
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
Baseline characteristics by cohort
| Measure |
IDN-6556 5 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=7 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
Placebo
n=4 Participants
Dosed twice daily
Placebo
|
Total
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
49.0 years
n=5 Participants
|
50.0 years
n=7 Participants
|
61.0 years
n=5 Participants
|
53.5 years
n=4 Participants
|
50.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
16 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: AUC\_0-last: The number of participants analyzed in the 25mg arm was 7 at Day 1 AUC\_0-inf: The number of participants analyzed in the 5mg arm was 2 at Day 1 and 0 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4. Values listed as "0" were non-estimable values.
Primary endpoints for AUC\_0-8, AUC\_0 last, AUC\_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.
Outcome measures
| Measure |
IDN-6556 5 mg
n=4 Number of Participants Analyzed at Day 4
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=4 Number of Participants Analyzed at Day 4
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Number of Participants Analyzed at Day 4
Dosed twice daily
IDN-6556
|
Placebo
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Area Under the Curve (AUC)
Day 1 AUC 0-8
|
275 h*ng/mL
Geometric Coefficient of Variation 40.0
|
1165 h*ng/mL
Geometric Coefficient of Variation 45.3
|
2397 h*ng/mL
Geometric Coefficient of Variation 99.3
|
—
|
|
Area Under the Curve (AUC)
Day 4 AUC 0-8
|
224.3 h*ng/mL
Geometric Coefficient of Variation 36.9
|
1767 h*ng/mL
Geometric Coefficient of Variation 31.4
|
2148 h*ng/mL
Geometric Coefficient of Variation 227.9
|
—
|
|
Area Under the Curve (AUC)
Day 1 AUC 0-last
|
275 h*ng/mL
Geometric Coefficient of Variation 40.0
|
1295 h*ng/mL
Geometric Coefficient of Variation 33.4
|
2997 h*ng/mL
Geometric Coefficient of Variation 103.8
|
—
|
|
Area Under the Curve (AUC)
Day 4 AUC 0-last
|
224.3 h*ng/mL
Geometric Coefficient of Variation 36.9
|
1818 h*ng/mL
Geometric Coefficient of Variation 27.8
|
2294 h*ng/mL
Geometric Coefficient of Variation 257.9
|
—
|
|
Area Under the Curve (AUC)
Day 4 AUC 0-inf
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
3447 h*ng/mL
Geometric Coefficient of Variation 188.2
|
—
|
|
Area Under the Curve (AUC)
Day 1 AUC 0-inf
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
1462 h*ng/mL
Geometric Coefficient of Variation 30.3
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
—
|
PRIMARY outcome
Timeframe: 28 DaysPrimary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.
Outcome measures
| Measure |
IDN-6556 5 mg
n=4 Number of Participants Analyzed at Day 4
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=5 Number of Participants Analyzed at Day 4
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Number of Participants Analyzed at Day 4
Dosed twice daily
IDN-6556
|
Placebo
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Cmax
Day 1 Cmax
|
84.4 (ng/mL)
Geometric Coefficient of Variation 43.9
|
329.8 (ng/mL)
Geometric Coefficient of Variation 48.3
|
696.1 (ng/mL)
Geometric Coefficient of Variation 117.4
|
—
|
|
Cmax
Day 4 Cmax
|
38.0 (ng/mL)
Geometric Coefficient of Variation 33.9
|
586.5 (ng/mL)
Geometric Coefficient of Variation 33.7
|
594.1 (ng/mL)
Geometric Coefficient of Variation 161.3
|
—
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: t1/2 number of participants analyzed at Day 1 in the 5mg arm was 2 and 1 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4. Values listed as "0" were non-estimable values.
Primary endpoints for tmax \& t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.
Outcome measures
| Measure |
IDN-6556 5 mg
n=4 Number of Participant Analyzed at Day 4
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=5 Number of Participant Analyzed at Day 4
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Number of Participant Analyzed at Day 4
Dosed twice daily
IDN-6556
|
Placebo
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Tmax & t1/2 Parameters
Day 1 tmax
|
3.0 (h)
Standard Deviation 1.3
|
2.9 (h)
Standard Deviation 1.5
|
3.6 (h)
Standard Deviation 3.0
|
—
|
|
Tmax & t1/2 Parameters
Day 4 tmax
|
3.8 (h)
Standard Deviation 3.4
|
2.7 (h)
Standard Deviation 1.8
|
3.5 (h)
Standard Deviation 2.8
|
—
|
|
Tmax & t1/2 Parameters
Day 1 t1/2
|
0 (h)
Standard Deviation 0
|
2.2 (h)
Standard Deviation 0.7
|
0 (h)
Standard Deviation 0
|
—
|
|
Tmax & t1/2 Parameters
Day 4 t1/2
|
0 (h)
Standard Deviation 0
|
0 (h)
Standard Deviation 0
|
3.4 (h)
Standard Deviation 2.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28Population: Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; "0" are non-estimable values
Caspase-cleaved cytokeratin serum levels (CK18/M30)
Outcome measures
| Measure |
IDN-6556 5 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=7 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
Placebo
n=3 Participants
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Levels of CK18/M30
Day 21
|
850 U/L
Interval 222.0 to 1478.0
|
770 U/L
Interval 298.0 to 1512.0
|
551 U/L
Interval 341.0 to 760.0
|
626 U/L
Interval 297.0 to 955.0
|
|
Levels of CK18/M30
Day 28
|
0 U/L
Interval 0.0 to 0.0
|
808 U/L
Interval 386.0 to 975.0
|
533 U/L
Interval 186.0 to 879.0
|
553 U/L
Interval 214.0 to 892.0
|
|
Levels of CK18/M30
Baseline
|
703 U/L
Interval 302.0 to 2162.0
|
1392 U/L
Interval 330.0 to 3593.0
|
919 U/L
Interval 395.0 to 1851.0
|
455 U/L
Interval 240.0 to 1716.0
|
|
Levels of CK18/M30
Day 2
|
465 U/L
Interval 323.0 to 1999.0
|
616 U/L
Interval 277.0 to 2162.0
|
348 U/L
Interval 179.0 to 1023.0
|
425 U/L
Interval 284.0 to 1496.0
|
|
Levels of CK18/M30
Day 4
|
717 U/L
Interval 427.0 to 2162.0
|
847 U/L
Interval 306.0 to 2016.0
|
362 U/L
Interval 237.0 to 822.0
|
634 U/L
Interval 297.0 to 970.0
|
|
Levels of CK18/M30
Day 7
|
562 U/L
Interval 331.0 to 2162.0
|
1226 U/L
Interval 326.0 to 1993.0
|
319 U/L
Interval 203.0 to 2985.0
|
466 U/L
Interval 278.0 to 1388.0
|
|
Levels of CK18/M30
Day 14
|
1307 U/L
Interval 452.0 to 2162.0
|
1149 U/L
Interval 325.0 to 2071.0
|
577 U/L
Interval 521.0 to 954.0
|
843 U/L
Interval 317.0 to 1369.0
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28Population: Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; "0" are non-estimable values
Caspase full-length cytokeratin serum levels CK18/M65
Outcome measures
| Measure |
IDN-6556 5 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=7 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
Placebo
n=3 Participants
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Levels of CK18/M65
Baseline
|
1345 U/L
Interval 876.0 to 2862.0
|
2819 U/L
Interval 277.0 to 3762.0
|
1946 U/L
Interval 705.0 to 6999.0
|
1324 U/L
Interval 507.0 to 2451.0
|
|
Levels of CK18/M65
Day 7
|
1364 U/L
Interval 751.0 to 3098.0
|
2601 U/L
Interval 733.0 to 6999.0
|
1997 U/L
Interval 695.0 to 4028.0
|
1086 U/L
Interval 614.0 to 1948.0
|
|
Levels of CK18/M65
Day 14
|
1961 U/L
Interval 893.0 to 3028.0
|
3067 U/L
Interval 1027.0 to 5971.0
|
1286 U/L
Interval 1010.0 to 3711.0
|
1310 U/L
Interval 686.0 to 1934.0
|
|
Levels of CK18/M65
Day 21
|
3809 U/L
Interval 619.0 to 6999.0
|
2039 U/L
Interval 400.0 to 3502.0
|
2500 U/L
Interval 987.0 to 4012.0
|
1125 U/L
Interval 721.0 to 1529.0
|
|
Levels of CK18/M65
Day 28
|
0 U/L
Interval 0.0 to 0.0
|
1825 U/L
Interval 654.0 to 1845.0
|
2119 U/L
Interval 532.0 to 3705.0
|
1027 U/L
Interval 500.0 to 1553.0
|
|
Levels of CK18/M65
Day 2
|
1058 U/L
Interval 702.0 to 3145.0
|
2116 U/L
Interval 157.0 to 3155.0
|
1287 U/L
Interval 665.0 to 4365.0
|
1195 U/L
Interval 531.0 to 2213.0
|
|
Levels of CK18/M65
Day 4
|
1237 U/L
Interval 1100.0 to 2664.0
|
2257 U/L
Interval 783.0 to 3033.0
|
1436 U/L
Interval 662.0 to 4566.0
|
990 U/L
Interval 548.0 to 1431.0
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28Population: Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; "0" are non-estimable values
Concentration of Caspase 3/7 Relative Light Units
Outcome measures
| Measure |
IDN-6556 5 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=7 Participants
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 Participants
Dosed twice daily
IDN-6556
|
Placebo
n=3 Participants
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Levels of Caspase 3/7 RLU
Baseline
|
4418 RLU
Interval 2516.0 to 6692.0
|
3967 RLU
Interval 2615.0 to 6884.0
|
4304 RLU
Interval 1135.0 to 5405.0
|
4074 RLU
Interval 3189.0 to 5331.0
|
|
Levels of Caspase 3/7 RLU
Day 4
|
3147 RLU
Interval 1479.0 to 6025.0
|
1136 RLU
Interval 741.0 to 15674.0
|
1204 RLU
Interval 657.0 to 4253.0
|
5853 RLU
Interval 5778.0 to 5928.0
|
|
Levels of Caspase 3/7 RLU
Day 7
|
4081 RLU
Interval 979.0 to 5611.0
|
1271 RLU
Interval 636.0 to 3794.0
|
958 RLU
Interval 603.0 to 1390.0
|
3917 RLU
Interval 2672.0 to 5269.0
|
|
Levels of Caspase 3/7 RLU
Day 14
|
2265 RLU
Interval 1214.0 to 3315.0
|
1180 RLU
Interval 434.0 to 1623.0
|
835 RLU
Interval 276.0 to 897.0
|
1869 RLU
Interval 1273.0 to 2465.0
|
|
Levels of Caspase 3/7 RLU
Day 21
|
2914 RLU
Interval 1948.0 to 3880.0
|
636 RLU
Interval 471.0 to 1105.0
|
962 RLU
Interval 833.0 to 1091.0
|
1590 RLU
Interval 970.0 to 2210.0
|
|
Levels of Caspase 3/7 RLU
Day 28
|
0 RLU
Interval 0.0 to 0.0
|
1208 RLU
Interval 679.0 to 2949.0
|
963 RLU
Interval 859.0 to 1066.0
|
1894 RLU
Interval 874.0 to 2914.0
|
|
Levels of Caspase 3/7 RLU
Day 2
|
2893 RLU
Interval 2222.0 to 6268.0
|
1487 RLU
Interval 842.0 to 3071.0
|
974 RLU
Interval 653.0 to 1323.0
|
3989 RLU
Interval 3934.0 to 4078.0
|
Adverse Events
IDN-6556 5 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
IDN-6556 25 mg
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
IDN-6556 50 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDN-6556 5 mg
n=5 participants at risk
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=7 participants at risk
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 participants at risk
Dosed twice daily
IDN-6556
|
Placebo
n=4 participants at risk
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
40.0%
2/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
General disorders
Multi-organ failure
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Nervous system disorders
Hepatic encephalopathy
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
Other adverse events
| Measure |
IDN-6556 5 mg
n=5 participants at risk
Dosed twice daily
IDN-6556
|
IDN-6556 25 mg
n=7 participants at risk
Dosed twice daily
IDN-6556
|
IDN-6556 50 mg
n=5 participants at risk
Dosed twice daily
IDN-6556
|
Placebo
n=4 participants at risk
Dosed twice daily
Placebo
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Cardiac disorders
Cardiac disorders
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Eye disorders
Eye disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
60.0%
3/5 • Adverse events data were collected for a period of 18 months.
|
100.0%
7/7 • Adverse events data were collected for a period of 18 months.
|
80.0%
4/5 • Adverse events data were collected for a period of 18 months.
|
75.0%
3/4 • Adverse events data were collected for a period of 18 months.
|
|
General disorders
General disorders and administration site conditions
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
42.9%
3/7 • Adverse events data were collected for a period of 18 months.
|
40.0%
2/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
40.0%
2/5 • Adverse events data were collected for a period of 18 months.
|
42.9%
3/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Infections and infestations
Infections and infestations
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
28.6%
2/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Investigations
Investigations
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
14.3%
1/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
75.0%
3/4 • Adverse events data were collected for a period of 18 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
28.6%
2/7 • Adverse events data were collected for a period of 18 months.
|
60.0%
3/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
28.6%
2/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Nervous system disorders
Nervous system disorders
|
40.0%
2/5 • Adverse events data were collected for a period of 18 months.
|
57.1%
4/7 • Adverse events data were collected for a period of 18 months.
|
40.0%
2/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Psychiatric disorders
Psychiatric disorders
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
28.6%
2/7 • Adverse events data were collected for a period of 18 months.
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
40.0%
2/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
25.0%
1/4 • Adverse events data were collected for a period of 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
57.1%
4/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
50.0%
2/4 • Adverse events data were collected for a period of 18 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
28.6%
2/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
|
Vascular disorders
Vascular disorders
|
20.0%
1/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/7 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/5 • Adverse events data were collected for a period of 18 months.
|
0.00%
0/4 • Adverse events data were collected for a period of 18 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60