Trial Outcomes & Findings for PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers (NCT NCT02039817)
NCT ID: NCT02039817
Last Updated: 2016-01-28
Results Overview
Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
48 hours
Results posted on
2016-01-28
Participant Flow
This was an open-label, multicenter, parallel-group study to compare the PK and PD of IDN 6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched subjects with normal renal function (healthy volunteers).
In total, 16 subjects were enrolled and dosed (8 subjects with severe renal impairment, and 8 healthy volunteers) with one 50mg dose of IDN-6556.
Participant milestones
| Measure |
Healthy Volumteers
Healthy volunteers were given a single 50mg dose of IDN-6556
|
Severe Renal Impairment
Severe Renal Impairment subjects were given a single 50mg dose of IDN-6556
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=8 Participants
Health Volunteers received one 50mg dose of IDN-6556
|
Severe Renal Impairment
n=8 Participants
Severe Renal Impairment subjects received one 50mg dose of IDN-6556
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=5 Participants
|
64.0 years
n=7 Participants
|
62.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: 7 subjects were used in the calculation of AUC0-inf for the healthy volunteer group as one subject had no identifiable terminal log-linear phase.
Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
Subjects received a single 50 mg oral dose of IDN-6556
|
Severe Renal Impairment
n=8 Participants
Subjects received a single 50 mg oral dose of IDN-6556
|
|---|---|---|
|
AUC
AUC 0-12 (h*ng/mL)
|
102.0 h*ng/mL
Geometric Coefficient of Variation 39.4
|
168.9 h*ng/mL
Geometric Coefficient of Variation 42.3
|
|
AUC
AUC 0-inf (h*ng/mL)
|
107.4 h*ng/mL
Geometric Coefficient of Variation 41.3
|
188.5 h*ng/mL
Geometric Coefficient of Variation 43.8
|
|
AUC
AUC last (h*ng/mL)
|
105.9 h*ng/mL
Geometric Coefficient of Variation 38.3
|
186.5 h*ng/mL
Geometric Coefficient of Variation 43.4
|
PRIMARY outcome
Timeframe: 48 hoursMaximum concentration (Cmax)
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
Subjects received a single 50 mg oral dose of IDN-6556
|
Severe Renal Impairment
n=8 Participants
Subjects received a single 50 mg oral dose of IDN-6556
|
|---|---|---|
|
Cmax
|
28.5 ng/mL
Geometric Coefficient of Variation 44
|
42.7 ng/mL
Geometric Coefficient of Variation 57
|
SECONDARY outcome
Timeframe: 48 hoursBiomarker cCK18 (Cleaved cytokeratin 18) PK evaluations from pre-dose to 48 hours
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
Subjects received a single 50 mg oral dose of IDN-6556
|
Severe Renal Impairment
n=8 Participants
Subjects received a single 50 mg oral dose of IDN-6556
|
|---|---|---|
|
Levels of cCK18
predose
|
240.0 U/L
Interval 165.5 to 336.0
|
223.5 U/L
Interval 155.0 to 288.5
|
|
Levels of cCK18
.5 hour
|
201.5 U/L
Interval 154.0 to 298.5
|
202.5 U/L
Interval 178.5 to 300.0
|
|
Levels of cCK18
1 hour
|
208.0 U/L
Interval 154.5 to 266.0
|
191.5 U/L
Interval 183.0 to 283.0
|
|
Levels of cCK18
2 hours
|
202.5 U/L
Interval 157.0 to 234.0
|
198.0 U/L
Interval 175.5 to 284.0
|
|
Levels of cCK18
3 hours
|
184.5 U/L
Interval 140.5 to 210.0
|
201.0 U/L
Interval 190.5 to 295.0
|
|
Levels of cCK18
4 hours
|
183.5 U/L
Interval 142.5 to 207.0
|
198.5 U/L
Interval 178.5 to 284.5
|
|
Levels of cCK18
5 hours
|
179.0 U/L
Interval 141.5 to 232.0
|
221.5 U/L
Interval 162.0 to 291.5
|
|
Levels of cCK18
8 hours
|
178.0 U/L
Interval 137.0 to 244.0
|
212.0 U/L
Interval 152.5 to 256.5
|
|
Levels of cCK18
12 hours
|
167.0 U/L
Interval 132.0 to 220.0
|
205.5 U/L
Interval 155.0 to 266.0
|
|
Levels of cCK18
24 hours
|
204.0 U/L
Interval 144.0 to 286.5
|
192.5 U/L
Interval 159.5 to 266.0
|
|
Levels of cCK18
48 hours
|
206.5 U/L
Interval 159.0 to 291.0
|
195.0 U/L
Interval 183.0 to 295.0
|
Adverse Events
IDN-6556
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60