Trial Outcomes & Findings for Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function. (NCT NCT03131479)
NCT ID: NCT03131479
Last Updated: 2021-01-05
Results Overview
Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Baseline , Day 7
Results posted on
2021-01-05
Participant Flow
This study was conducted at 1 centers in the United States.
Participant milestones
| Measure |
Mild
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
Normal
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
12
|
10
|
|
Overall Study
Safety Analysis Set (SS)
|
10
|
10
|
11
|
12
|
10
|
|
Overall Study
Pharmacokinetic Analysis Set (PAS)
|
10
|
10
|
11
|
12
|
10
|
|
Overall Study
Pharcodynamic Analysis Set (PD)
|
10
|
10
|
11
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Mild
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
Normal
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Subject/Guardian Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
Baseline characteristics by cohort
| Measure |
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
66.3 Years
STANDARD_DEVIATION 8.10 • n=7 Participants
|
65.8 Years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
63.3 Years
STANDARD_DEVIATION 12.66 • n=4 Participants
|
59.3 Years
STANDARD_DEVIATION 8.17 • n=21 Participants
|
64.0 Years
STANDARD_DEVIATION 9.66 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=10 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
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
|
24-hour Urinary glucose excretion (UGE)
|
4.7 gram (g)
STANDARD_DEVIATION 9.96 • n=5 Participants
|
2.9 gram (g)
STANDARD_DEVIATION 6.27 • n=7 Participants
|
0.1 gram (g)
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.3 gram (g)
STANDARD_DEVIATION 0.77 • n=4 Participants
|
0.1 gram (g)
STANDARD_DEVIATION 0.07 • n=21 Participants
|
1.5 gram (g)
STANDARD_DEVIATION 5.25 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline , Day 7Population: Pharmacodynamic Analysis Set (PD), which consisted of all participants with an observed PD value, was considered. Only patients with evaluable data at each time point were analyzed for that time point.
Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7
|
40.45 gram (g)
Standard Deviation 21.93
|
31.87 gram (g)
Standard Deviation 13.79
|
36.27 gram (g)
Standard Deviation 19.51
|
19.88 gram (g)
Standard Deviation 18.66
|
5.50 gram (g)
Standard Deviation 3.75
|
PRIMARY outcome
Timeframe: Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for LIK066
Day 7
|
650 nanogram per milliliter (ng/mL)
Standard Deviation 250
|
678 nanogram per milliliter (ng/mL)
Standard Deviation 219
|
686 nanogram per milliliter (ng/mL)
Standard Deviation 243
|
743 nanogram per milliliter (ng/mL)
Standard Deviation 301
|
800 nanogram per milliliter (ng/mL)
Standard Deviation 268
|
|
Maximum Observed Plasma Concentration (Cmax) for LIK066
Day 1
|
565 nanogram per milliliter (ng/mL)
Standard Deviation 176
|
590 nanogram per milliliter (ng/mL)
Standard Deviation 176
|
492 nanogram per milliliter (ng/mL)
Standard Deviation 142
|
569 nanogram per milliliter (ng/mL)
Standard Deviation 147
|
650 nanogram per milliliter (ng/mL)
Standard Deviation 199
|
PRIMARY outcome
Timeframe: Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066
Day 1
|
1.00 hour (hr)
Interval 0.5 to 4.03
|
1.00 hour (hr)
Interval 0.5 to 4.0
|
1.00 hour (hr)
Interval 1.0 to 8.0
|
1.00 hour (hr)
Interval 0.5 to 3.0
|
1.00 hour (hr)
Interval 0.5 to 4.0
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066
Day 7
|
1.00 hour (hr)
Interval 0.5 to 3.0
|
1.03 hour (hr)
Interval 0.5 to 4.0
|
1.00 hour (hr)
Interval 0.5 to 6.0
|
1.00 hour (hr)
Interval 0.5 to 2.0
|
1.00 hour (hr)
Interval 0.5 to 2.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066
Day 1
|
2830 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 650
|
3330 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 563
|
3120 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 567
|
3360 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 886
|
4150 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1040
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066
Day 7
|
3440 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 790
|
4170 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 981
|
4080 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1040
|
4510 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1240
|
6290 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 2280
|
PRIMARY outcome
Timeframe: Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7
|
4190 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1090
|
5280 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1540
|
5440 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1740
|
6410 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 2160
|
9620 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 3910
|
PRIMARY outcome
Timeframe: Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1
|
310 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 688
|
3610 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 649
|
3440 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 551
|
3520 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1000
|
4450 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 1480
|
PRIMARY outcome
Timeframe: Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to \~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-life (T1/2) for LIK066 on Day 7
|
22.9 hour (hr)
Standard Deviation 20.3
|
21.8 hour (hr)
Standard Deviation 10.8
|
21.1 hour (hr)
Standard Deviation 9.25
|
20.9 hour (hr)
Standard Deviation 8.91
|
22.8 hour (hr)
Standard Deviation 9.52
|
PRIMARY outcome
Timeframe: Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1
|
17.4 Liter per hour (L/h)
Standard Deviation 4.20
|
14.3 Liter per hour (L/h)
Standard Deviation 2.59
|
14.9 Liter per hour (L/h)
Standard Deviation 2.55
|
15.4 Liter per hour (L/h)
Standard Deviation 4.87
|
12.4 Liter per hour (L/h)
Standard Deviation 4.53
|
PRIMARY outcome
Timeframe: Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.
Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1
|
160 Liter (L)
Standard Deviation 59.4
|
140 Liter (L)
Standard Deviation 28.6
|
164 Liter (L)
Standard Deviation 79.9
|
176 Liter (L)
Standard Deviation 67.8
|
134 Liter (L)
Standard Deviation 50.5
|
PRIMARY outcome
Timeframe: Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)Population: Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.
Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Outcome measures
| Measure |
Normal
n=10 Participants
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 Participants
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 Participants
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 Participants
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 Participants
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Renal Clearance From Plasma (CLr) for LIK066
Day 1
|
0.389 Liter per hour (L/hr)
Standard Deviation 0.179
|
0.348 Liter per hour (L/hr)
Standard Deviation 0.141
|
0.259 Liter per hour (L/hr)
Standard Deviation 0.114
|
0.173 Liter per hour (L/hr)
Standard Deviation 0.0919
|
0.0522 Liter per hour (L/hr)
Standard Deviation 0.0237
|
|
Renal Clearance From Plasma (CLr) for LIK066
Day 7
|
0.474 Liter per hour (L/hr)
Standard Deviation 0.275
|
0.367 Liter per hour (L/hr)
Standard Deviation 0.0815
|
0.294 Liter per hour (L/hr)
Standard Deviation 0.119
|
0.174 Liter per hour (L/hr)
Standard Deviation 0.0636
|
0.0694 Liter per hour (L/hr)
Standard Deviation 0.0461
|
Adverse Events
Normal
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Mild
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Moderate A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Moderate B
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Severe
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal
n=10 participants at risk
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 participants at risk
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 participants at risk
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 participants at risk
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 participants at risk
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
Other adverse events
| Measure |
Normal
n=10 participants at risk
Patients with normal renal function (Group 5) received LIK066 50 mg qd before breakfast for 7 days.
|
Mild
n=10 participants at risk
Patients with mild renal impairment (Group 1) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate A
n=10 participants at risk
Patients with moderate renal impairment grade A (Group 2) received LIK066 50 mg qd before breakfast for 7 days.
|
Moderate B
n=11 participants at risk
Patients with moderate renal impairment grade B (Group 3) received LIK066 50 mg qd before breakfast for 7 days.
|
Severe
n=12 participants at risk
Patients with severe renal impairment (Group 4) received LIK066 50 mg qd before breakfast for 7 days.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
20.0%
2/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
10.0%
1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
27.3%
3/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
25.0%
3/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Gastrointestinal disorders
Diarrhoea
|
90.0%
9/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
100.0%
10/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
100.0%
10/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
90.9%
10/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
91.7%
11/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Gastrointestinal disorders
Flatulence
|
70.0%
7/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
70.0%
7/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
60.0%
6/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
81.8%
9/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
58.3%
7/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
10.0%
1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
8.3%
1/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/10 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
9.1%
1/11 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
0.00%
0/12 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER