Trial Outcomes & Findings for A Study of Abemaciclib in Healthy Participants (NCT NCT02672423)
NCT ID: NCT02672423
Last Updated: 2019-01-04
Results Overview
Area under the concentration versus time curve from zero to infinity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
127 participants
Primary outcome timeframe
Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose
Results posted on
2019-01-04
Participant Flow
A 2- and 3-period crossover study conducted in 3 parts, with Part A followed by Parts B and C. Participants received single oral doses of abemaciclib on 2 separate occasions in Parts A and C and on 3 separate occasions in Part B.There was a washout interval of at least 16 days between periods.
Participant milestones
| Measure |
Part A: Abemaciclib (R,T150 )
Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
|
Part A: Abemaciclib (T150,R)
T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 2 periods.
|
Part B: Abemaciclib (R,T150,T50 )
R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T150,T50,R)
T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T50,R,T150)
T50 = 3 x 50 mg abemaciclib tablets, R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (R,T50,T150)
R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T150,R,T50)
T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T50,T150,R)
T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 3 periods.
|
Part C: Abemaciclib (T150 Fed, T150 Fasted)
T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
|
Part C: Abemaciclib (T150 Fasted, T150 Fed)
T150 Fasted and T150 Fed = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
14
|
15
|
15
|
15
|
15
|
15
|
12
|
12
|
|
Period 1
Received at Least One Dose of Study Drug
|
7
|
7
|
14
|
15
|
15
|
15
|
15
|
15
|
12
|
12
|
|
Period 1
COMPLETED
|
7
|
7
|
14
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1
STARTED
|
7
|
7
|
14
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Washout 1
COMPLETED
|
7
|
7
|
14
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Washout 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
7
|
14
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Period 2
COMPLETED
|
7
|
7
|
13
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2
STARTED
|
7
|
7
|
13
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Washout 2
COMPLETED
|
7
|
7
|
13
|
15
|
14
|
15
|
15
|
15
|
12
|
12
|
|
Washout 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
0
|
13
|
15
|
14
|
15
|
15
|
15
|
0
|
0
|
|
Period 3
COMPLETED
|
0
|
0
|
13
|
15
|
14
|
14
|
15
|
14
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Abemaciclib (R,T150 )
Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
|
Part A: Abemaciclib (T150,R)
T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 2 periods.
|
Part B: Abemaciclib (R,T150,T50 )
R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T150,T50,R)
T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T50,R,T150)
T50 = 3 x 50 mg abemaciclib tablets, R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (R,T50,T150)
R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T150,R,T50)
T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules, T50 = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part B: Abemaciclib (T50,T150,R)
T50 = 3 x 50 mg abemaciclib tablets, T150 = 150 mg abemaciclib tablet, R = 3 x 50 mg abemaciclib capsules administered orally on Day 1 in each of 3 periods.
|
Part C: Abemaciclib (T150 Fed, T150 Fasted)
T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
|
Part C: Abemaciclib (T150 Fasted, T150 Fed)
T150 Fasted and T150 Fed = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 3
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Abemaciclib in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A: Abemaciclib
n=14 Participants
Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
|
Part B Abemaciclib
n=89 Participants
R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
|
Part C Abemaciclib
n=24 Participants
T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 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
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Area under the concentration versus time curve from zero to infinity.
Outcome measures
| Measure |
Part A: 150 mg Abemaciclib (T150)
n=13 Participants
150 mg abemaciclib tablet (test formulation\[T150\]) administered orally on Day 1 of 1 period.
|
Part A: 3 x 50 mg Abemaciclib (R)
n=12 Participants
3 x 50 mg abemaciclib capsules (reference formulation\[R\]) administered orally on Day 1 of 1 period.
|
Part B: 150 mg Abemaciclib (T150)
n=82 Participants
150 mg abemaciclib tablet (test formulation\[T150\]) administered orally on Day 1 of 1 period.
|
Part B: 3 x 50 mg Abemaciclib (T50)
n=85 Participants
3 x 50 mg abemaciclib tablets (T50) administered orally on Day 1 of 1 period.
|
Part B: 3 x 50 mg Abemaciclib (R)
n=84 Participants
3 x 50 mg abemaciclib capsules (reference formulation\[R\]) administered orally on Day 1 of 1 period.
|
Part C: 150 mg Abemaciclib (Fed)
n=23 Participants
150 mg abemaciclib tablet (test formulation \[T150\]) with a meal administered orally on Day 1 of 1 period.
|
Part C: 150 mg Abemaciclib (Fasted)
n=24 Participants
150 mg abemaciclib tablet (test formulation\[T150\]) without a meal administered orally on Day 1 of 1 period.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
|
3080 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 57
|
2880 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 56
|
3110 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
3120 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 52
|
3130 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 59
|
4170 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
3590 Nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45
|
PRIMARY outcome
Timeframe: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Maximum observed drug concentration.
Outcome measures
| Measure |
Part A: 150 mg Abemaciclib (T150)
n=13 Participants
150 mg abemaciclib tablet (test formulation\[T150\]) administered orally on Day 1 of 1 period.
|
Part A: 3 x 50 mg Abemaciclib (R)
n=12 Participants
3 x 50 mg abemaciclib capsules (reference formulation\[R\]) administered orally on Day 1 of 1 period.
|
Part B: 150 mg Abemaciclib (T150)
n=82 Participants
150 mg abemaciclib tablet (test formulation\[T150\]) administered orally on Day 1 of 1 period.
|
Part B: 3 x 50 mg Abemaciclib (T50)
n=85 Participants
3 x 50 mg abemaciclib tablets (T50) administered orally on Day 1 of 1 period.
|
Part B: 3 x 50 mg Abemaciclib (R)
n=84 Participants
3 x 50 mg abemaciclib capsules (reference formulation\[R\]) administered orally on Day 1 of 1 period.
|
Part C: 150 mg Abemaciclib (Fed)
n=23 Participants
150 mg abemaciclib tablet (test formulation \[T150\]) with a meal administered orally on Day 1 of 1 period.
|
Part C: 150 mg Abemaciclib (Fasted)
n=24 Participants
150 mg abemaciclib tablet (test formulation\[T150\]) without a meal administered orally on Day 1 of 1 period.
|
|---|---|---|---|---|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax)
|
104 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
101 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
95.2 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
97.7 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
95.8 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
130 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
99.6 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
Adverse Events
Part A: 3 x 50 mg (R)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: 1 x 150 mg (T150)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: 3 x 50 mg (R)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Part B 1 x 150 mg (T150)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part B 3 x 50 mg (T50)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Part C: (T150 Fed, T150 Fasted)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part C: (T150 Fasted, T150 Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: 3 x 50 mg (R)
n=14 participants at risk
3 x 50 milligrams (mg) abemaciclib capsules (reference formulation \[R\]) administered orally on Day 1 of 1 period.
|
Part A: 1 x 150 mg (T150)
n=14 participants at risk
150 mg abemaciclib tablet (test formulation\[T150\]) administered orally on Day 1 of 1 period.
|
Part B: 3 x 50 mg (R)
n=88 participants at risk
3 x 50 milligrams (mg) abemaciclib capsules (reference formulation\[R\]) administered orally on Day 1 of 1 period.
|
Part B 1 x 150 mg (T150)
n=87 participants at risk
150 mg abemaciclib tablet (test formulation\[T150\]) administered orally on Day 1 of 1 period.
|
Part B 3 x 50 mg (T50)
n=88 participants at risk
3 x 50 mg abemaciclib tablets (test formulation\[T50\]) administered orally on Day 1 of 1 period.
|
Part C: (T150 Fed, T150 Fasted)
n=24 participants at risk
150 mg abemaciclib tablet (test formulation \[T150\]) with a meal and then without a meal administered orally on Day 1 of 1 period..
|
Part C: (T150 Fasted, T150 Fed)
n=24 participants at risk
150 mg abemaciclib tablet (test formulation \[T150\]) without a meal and then with a meal administered orally on Day 1 of 1 period.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
2.3%
2/88 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
3.4%
3/87 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.5%
4/88 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.5%
4/88 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.5%
4/88 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
5.7%
5/88 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/87
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
9.1%
8/88 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
10.3%
9/87 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
13.6%
12/88 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.5%
4/88 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.6%
4/87 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
5.7%
5/88 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/87
All randomized participants who received at least one dose of study drug.
|
1.1%
1/88 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.3%
2/88 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
12.5%
11/88 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
8.0%
7/87 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
8.0%
7/88 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/87
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/87
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/87
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/87
All randomized participants who received at least one dose of study drug.
|
0.00%
0/88
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of study drug.
|
0.00%
0/24
All randomized participants who received at least one dose of 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