Trial Outcomes & Findings for A Study of Abemaciclib in Healthy Participants (NCT NCT02677844)
NCT ID: NCT02677844
Last Updated: 2019-01-04
Results Overview
QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder. Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose
Results posted on
2019-01-04
Participant Flow
Dose escalation study with 2 cohorts, participants in cohort 1 were randomized to 1 of 4 sequences \& participants in cohort 2 were randomized to 1 of 3 sequences. Cohort 1 had periods 1 to 4 with at least 5 days washout between each dose, Cohort 2 had periods 4(DDI) to 7 with at least 8 days washout between each dose.
Participant milestones
| Measure |
Cohort 1 Sequence 1
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 1- Placebo; Period 2- 200 milligram (mg) Abemaciclib; Period 3- 300 mg Abemaciclib; Period 4- 400 mg Abemaciclib.
|
Cohort 1 Sequence 2
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 1- 200 mg Abemaciclib; Period 2- Placebo; Period 3- 300 mg Abemaciclib; Period 4- 400 mg Abemaciclib.
|
Cohort 1 Sequence 3
Abemaciclib matching placebo was administered orally on day 1 of each period based on below dosing schedule.
Period 1- 200 mg Abemaciclib; Period 2- 300 mg Abemaciclib; Period 3- Placebo; Period 4- 400 mg Abemaciclib.
|
Cohort 1 Sequence 4
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 1- 200 mg Abemaciclib; Period 2- 300 mg Abemaciclib; Period 3- 400 mg Abemaciclib; Period 4- Placebo.
|
Cohort 2 Sequence 1
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 4 (DDI)- 8 mg Loperamide (on day -3 \& 1) \& Placebo; Period 5- Placebo; Period 6- 400 mg Abemaciclib; Period 7- 600 mg Abemaciclib.
|
Cohort 2 Sequence 2
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 4 (DDI)- 8 mg Loperamide (on Day -3 \& 1) \& 400 mg Abemaciclib; Period 5- 400 mg Abemaciclib; Period 6- Placebo; Period 7- 600 mg Abemaciclib.
|
Cohort 2 Sequence 3
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 4 (DDI)- 8 mg Loperamide (on day -3 \& 1) \& 400 mg Abemaciclib; Period 5- 400 mg Abemaciclib; Period 6- 600 mg Abemaciclib; Period 7- Placebo.
|
|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
5
|
5
|
5
|
5
|
0
|
0
|
0
|
|
Period 3
COMPLETED
|
5
|
5
|
5
|
4
|
0
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 4
STARTED
|
5
|
5
|
5
|
4
|
0
|
0
|
0
|
|
Period 4
COMPLETED
|
5
|
5
|
5
|
4
|
0
|
0
|
0
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 (DDI)
STARTED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 4 (DDI)
COMPLETED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 4 (DDI)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
STARTED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 5
COMPLETED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 6
STARTED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 6
COMPLETED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 7
STARTED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 7
COMPLETED
|
0
|
0
|
0
|
0
|
7
|
4
|
4
|
|
Period 7
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Sequence 1
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 1- Placebo; Period 2- 200 milligram (mg) Abemaciclib; Period 3- 300 mg Abemaciclib; Period 4- 400 mg Abemaciclib.
|
Cohort 1 Sequence 2
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 1- 200 mg Abemaciclib; Period 2- Placebo; Period 3- 300 mg Abemaciclib; Period 4- 400 mg Abemaciclib.
|
Cohort 1 Sequence 3
Abemaciclib matching placebo was administered orally on day 1 of each period based on below dosing schedule.
Period 1- 200 mg Abemaciclib; Period 2- 300 mg Abemaciclib; Period 3- Placebo; Period 4- 400 mg Abemaciclib.
|
Cohort 1 Sequence 4
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 1- 200 mg Abemaciclib; Period 2- 300 mg Abemaciclib; Period 3- 400 mg Abemaciclib; Period 4- Placebo.
|
Cohort 2 Sequence 1
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 4 (DDI)- 8 mg Loperamide (on day -3 \& 1) \& Placebo; Period 5- Placebo; Period 6- 400 mg Abemaciclib; Period 7- 600 mg Abemaciclib.
|
Cohort 2 Sequence 2
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 4 (DDI)- 8 mg Loperamide (on Day -3 \& 1) \& 400 mg Abemaciclib; Period 5- 400 mg Abemaciclib; Period 6- Placebo; Period 7- 600 mg Abemaciclib.
|
Cohort 2 Sequence 3
Abemaciclib or matching placebo was administered orally on day 1 of each period based on below dosing schedule:
Period 4 (DDI)- 8 mg Loperamide (on day -3 \& 1) \& 400 mg Abemaciclib; Period 5- 400 mg Abemaciclib; Period 6- 600 mg Abemaciclib; Period 7- Placebo.
|
|---|---|---|---|---|---|---|---|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Abemaciclib in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1
n=20 Participants
Single ascending doses of 200, 300, and 400 mg of Abemaciclib \& Placebo were administered orally in one of the four sequences in each period.
|
Cohort 2
n=15 Participants
Single ascending doses of 400, 600 mg Abemaciclib \& Placebo were administered orally in one of the four sequences in each period. Loperamide 8mg was administered orally in period 4 (DDI) along with Abemaciclib.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
58 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.80 Kilogram per square meter (Kg/m^2)
STANDARD_DEVIATION 3.15 • n=5 Participants
|
27.55 Kilogram per square meter (Kg/m^2)
STANDARD_DEVIATION 2.35 • n=7 Participants
|
27.12 Kilogram per square meter (Kg/m^2)
STANDARD_DEVIATION 2.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post DosePopulation: All randomized participants who received at least one dose of study drug and had baseline and post baseline QTcF values.
QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder. Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves.
Outcome measures
| Measure |
200 mg Abemaciclib
n=19 Participants
200 mg Abemaciclib was given orally.
|
300 mg Abemaciclib
n=19 Participants
300 mg Abemaciclib was given orally.
|
400 mg Abemaciclib
n=33 Participants
400mg Abemaciclib was given orally.
|
600 mg Abemaciclib
n=15 Participants
600 mg Abemaciclib was given orally.
|
400 mg Abemaciclib + Loperamide 8mg
400 mg Abemaciclib was given orally along with 8mg Loperamide.
|
|---|---|---|---|---|---|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
2hr
|
1.4 Millisecond (msec)
Interval -0.4 to 4.8
|
3.3 Millisecond (msec)
Interval -2.1 to 4.3
|
0.2 Millisecond (msec)
Interval -3.7 to 1.3
|
-2.1 Millisecond (msec)
Interval -7.3 to 0.6
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
4hr
|
-2.0 Millisecond (msec)
Interval -5.1 to 1.6
|
0.8 Millisecond (msec)
Interval -4.5 to 0.8
|
-0.7 Millisecond (msec)
Interval -4.9 to 0.6
|
-4.2 Millisecond (msec)
Interval -9.9 to 0.9
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
6hr
|
0.6 Millisecond (msec)
Interval -1.5 to 5.2
|
-0.2 Millisecond (msec)
Interval -5.8 to 1.2
|
-1.8 Millisecond (msec)
Interval -5.9 to -0.1
|
-3.7 Millisecond (msec)
Interval -10.3 to -0.8
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
8hr
|
2.8 Millisecond (msec)
Interval 0.7 to 6.4
|
2.7 Millisecond (msec)
Interval -3.1 to 4.0
|
2.2 Millisecond (msec)
Interval -1.8 to 3.5
|
2.8 Millisecond (msec)
Interval -3.9 to 5.8
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
10hr
|
2.1 Millisecond (msec)
Interval 0.6 to 5.1
|
1.3 Millisecond (msec)
Interval -3.7 to 1.7
|
1.5 Millisecond (msec)
Interval -2.4 to 2.1
|
5.9 Millisecond (msec)
Interval -2.8 to 11.0
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
12hr
|
-0.3 Millisecond (msec)
Interval -4.7 to 5.6
|
-0.7 Millisecond (msec)
Interval -6.6 to 0.8
|
-0.5 Millisecond (msec)
Interval -4.4 to 0.1
|
4.4 Millisecond (msec)
Interval -0.9 to 7.2
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
14hr
|
3.9 Millisecond (msec)
Interval 1.4 to 7.9
|
3.3 Millisecond (msec)
Interval -2.1 to 4.1
|
1.0 Millisecond (msec)
Interval -3.9 to 2.6
|
2.3 Millisecond (msec)
Interval -4.4 to 5.4
|
—
|
|
Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
24hr
|
1.4 Millisecond (msec)
Interval -1.2 to 5.5
|
4.2 Millisecond (msec)
Interval -0.7 to 4.8
|
-0.4 Millisecond (msec)
Interval -4.7 to 1.3
|
0.9 Millisecond (msec)
Interval -7.1 to 4.6
|
—
|
SECONDARY outcome
Timeframe: Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post DosePopulation: All randomized participants who received at least one dose of study drug in Cohort 1 all periods \& Cohort 2 periods 5,6, and 7 with evaluable PK data.
Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib.
Outcome measures
| Measure |
200 mg Abemaciclib
n=19 Participants
200 mg Abemaciclib was given orally.
|
300 mg Abemaciclib
n=20 Participants
300 mg Abemaciclib was given orally.
|
400 mg Abemaciclib
n=31 Participants
400mg Abemaciclib was given orally.
|
600 mg Abemaciclib
n=8 Participants
600 mg Abemaciclib was given orally.
|
400 mg Abemaciclib + Loperamide 8mg
n=7 Participants
400 mg Abemaciclib was given orally along with 8mg Loperamide.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib
|
102 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
130 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
182 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
308 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
199 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 55
|
SECONDARY outcome
Timeframe: Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post DosePopulation: All randomized participants who received at least one dose of study drug in Cohort 1 all periods \& Cohort 2 periods 5,6, and 7 with evaluable PK data.
Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib 0-tlast.
Outcome measures
| Measure |
200 mg Abemaciclib
n=19 Participants
200 mg Abemaciclib was given orally.
|
300 mg Abemaciclib
n=20 Participants
300 mg Abemaciclib was given orally.
|
400 mg Abemaciclib
n=31 Participants
400mg Abemaciclib was given orally.
|
600 mg Abemaciclib
n=8 Participants
600 mg Abemaciclib was given orally.
|
400 mg Abemaciclib + Loperamide 8mg
n=7 Participants
400 mg Abemaciclib was given orally along with 8mg Loperamide.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Last Time Point With Measurable Concentration AUC(0-tlast) of Abemaciclib
|
3560 ng*hr/mL
Geometric Coefficient of Variation 38
|
5210 ng*hr/mL
Geometric Coefficient of Variation 37
|
7610 ng*hr/mL
Geometric Coefficient of Variation 46
|
14600 ng*hr/mL
Geometric Coefficient of Variation 42
|
9420 ng*hr/mL
Geometric Coefficient of Variation 57
|
SECONDARY outcome
Timeframe: Day -3: Predose, 1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post DosePopulation: All randomized participants in Cohort 2 Period 4 (DDI) who received Loperamide \& had evaluable PK data.
Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.
Outcome measures
| Measure |
200 mg Abemaciclib
n=18 Participants
200 mg Abemaciclib was given orally.
|
300 mg Abemaciclib
n=7 Participants
300 mg Abemaciclib was given orally.
|
400 mg Abemaciclib
400mg Abemaciclib was given orally.
|
600 mg Abemaciclib
600 mg Abemaciclib was given orally.
|
400 mg Abemaciclib + Loperamide 8mg
400 mg Abemaciclib was given orally along with 8mg Loperamide.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point With Measurable Concentration [AUC(0-tlast)] of Loperamide
|
46.1 ng*hr/mL
Geometric Coefficient of Variation 47
|
47.3 ng*hr/mL
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3: Predose,1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post DosePopulation: All randomized participants in Cohort 2 Period 4 (DDI) who received Loperamide \& had evaluable PK data.
Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.
Outcome measures
| Measure |
200 mg Abemaciclib
n=18 Participants
200 mg Abemaciclib was given orally.
|
300 mg Abemaciclib
n=7 Participants
300 mg Abemaciclib was given orally.
|
400 mg Abemaciclib
400mg Abemaciclib was given orally.
|
600 mg Abemaciclib
600 mg Abemaciclib was given orally.
|
400 mg Abemaciclib + Loperamide 8mg
400 mg Abemaciclib was given orally along with 8mg Loperamide.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Loperamide
|
1.83 ng/mL
Geometric Coefficient of Variation 56
|
2.17 ng/mL
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
200 mg Abemaciclib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
300 mg Abemaciclib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
400 mg Abemaciclib
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
600 mg Abemaciclib
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
8 mg Loperamide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
8 mg Loperamide + Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
8 mg Loperamide + 400 mg Abemaciclib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=34 participants at risk
Matching placebo was given orally in place of Abemaciclib.
|
200 mg Abemaciclib
n=20 participants at risk
200 mg Abemaciclib was given orally.
|
300 mg Abemaciclib
n=20 participants at risk
300 mg Abemaciclib was given orally.
|
400 mg Abemaciclib
n=35 participants at risk
400 mg Abemaciclib was given orally.
|
600 mg Abemaciclib
n=15 participants at risk
600 mg Abemaciclib was given orally.
|
8 mg Loperamide
n=15 participants at risk
8 mg Loperamide was given orally.
|
8 mg Loperamide + Placebo
n=7 participants at risk
8 mg Loperamide was given orally \& matching placebo was used for Abemaciclib
|
8 mg Loperamide + 400 mg Abemaciclib
n=8 participants at risk
400 mg Abemaciclib was given orally along with 8 mg Loperamide.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
2.9%
1/35 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
25.0%
2/8 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
13.3%
2/15 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
28.6%
2/7 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
3/34 • Number of events 4 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.0%
1/20 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
20.0%
4/20 • Number of events 4 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
31.4%
11/35 • Number of events 11 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
73.3%
11/15 • Number of events 13 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
12.5%
1/8 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.7%
2/35 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
12.5%
1/8 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
14.3%
1/7 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
15.0%
3/20 • Number of events 3 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
17.1%
6/35 • Number of events 6 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
53.3%
8/15 • Number of events 9 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
14.3%
1/7 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
25.0%
2/8 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.0%
1/20 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.7%
2/35 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
40.0%
6/15 • Number of events 6 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
12.5%
1/8 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
General disorders
Application site irritation
|
8.8%
3/34 • Number of events 3 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.0%
1/20 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
General disorders
Asthenia
|
5.9%
2/34 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
14.3%
1/7 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
General disorders
Malaise
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
General disorders
Tenderness
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
2.9%
1/35 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
14.3%
1/7 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
28.6%
2/7 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
25.0%
2/8 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
28.6%
2/7 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
25.0%
2/8 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.0%
1/20 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
2.9%
1/35 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
25.0%
2/8 • Number of events 2 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
5.0%
1/20 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
8.6%
3/35 • Number of events 3 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
26.7%
4/15 • Number of events 4 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
14.3%
1/7 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
14.3%
1/7 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
6.7%
1/15 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/8 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/34 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/20 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/35 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/15 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
0.00%
0/7 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
12.5%
1/8 • Number of events 1 • Up to 117 days
All randomized participants who received at least once dose study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60