Trial Outcomes & Findings for A Study of LY2216684 in Healthy Participants Receiving Albuterol or Propanolol (NCT NCT01263197)
NCT ID: NCT01263197
Last Updated: 2019-01-29
Results Overview
Using a Holter monitor, heart rate was recorded every 10 minutes through 24 hours postdose on Days 1, 3, and 5 of each period. Baseline heart rate was the average of 10-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose heart rate was summarized over 1-hour increments using the average of the 10-minute readings within these intervals. The postdose heart rate for a day was the average heart rate for 24 hours. The least squares (LS) mean change from baseline heart rate is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 10 minutes through 24 hours postdose)
Results posted on
2019-01-29
Participant Flow
This was a 3-period, crossover study conducted in 2 groups. Participants were randomized to 1 of 3 sequences in either the albuterol group (Group 1) or 1 of 3 sequences in the propranolol group (Group 2).
Participant milestones
| Measure |
Group 1, Seq 1: LY2216684, Albuterol, LY2216684+Albuterol
Group 1, Sequence (Seq) 1
First intervention: LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.
Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 1, Seq 2: Albuterol, LY2216684+Albuterol, LY2216684
Group 1, Sequence 2
First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 1, Seq 3: LY2216684+Albuterol, LY2216684, Albuterol
Group 1, Sequence 3
First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.
Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 2, Seq 1: LY2216684, Propranolol, LY2216684+Propranolol
Group 2, Sequence 1
First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.
Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 2, Seq 2: Propranolol, LY2216684+Propranolol, LY2216684
Group 2, Sequence 2
First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 2, Seq 3: LY2216684+Propranolol, LY2216684, Propranolol
Group 2, Sequence 3
First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.
Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
|---|---|---|---|---|---|---|
|
First Intervention (Period 1)
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
First Intervention (Period 1)
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
First Intervention (Period 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 1
STARTED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Washout Period 1
COMPLETED
|
8
|
8
|
8
|
8
|
7
|
7
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Second Intervention (Period 2)
STARTED
|
8
|
8
|
8
|
8
|
7
|
7
|
|
Second Intervention (Period 2)
COMPLETED
|
8
|
8
|
8
|
8
|
7
|
7
|
|
Second Intervention (Period 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
8
|
8
|
8
|
8
|
7
|
7
|
|
Washout Period 2
COMPLETED
|
8
|
8
|
8
|
7
|
7
|
6
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Third Intervention (Period 3)
STARTED
|
8
|
8
|
8
|
7
|
7
|
6
|
|
Third Intervention (Period 3)
COMPLETED
|
8
|
7
|
8
|
7
|
7
|
6
|
|
Third Intervention (Period 3)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1, Seq 1: LY2216684, Albuterol, LY2216684+Albuterol
Group 1, Sequence (Seq) 1
First intervention: LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.
Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 1, Seq 2: Albuterol, LY2216684+Albuterol, LY2216684
Group 1, Sequence 2
First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 1, Seq 3: LY2216684+Albuterol, LY2216684, Albuterol
Group 1, Sequence 3
First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5.
Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 2, Seq 1: LY2216684, Propranolol, LY2216684+Propranolol
Group 2, Sequence 1
First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.
Second intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 2, Seq 2: Propranolol, LY2216684+Propranolol, LY2216684
Group 2, Sequence 2
First intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Third intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
Group 2, Seq 3: LY2216684+Propranolol, LY2216684, Propranolol
Group 2, Sequence 3
First intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
Second intervention: LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5.
Third intervention: Oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5.
There was a minimum 7-day washout between each intervention period.
|
|---|---|---|---|---|---|---|
|
First Intervention (Period 1)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 1
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period 2
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 2
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Third Intervention (Period 3)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2216684 in Healthy Participants Receiving Albuterol or Propanolol
Baseline characteristics by cohort
| Measure |
Group 1, Any Sequence (LY2216684, Albuterol, or Placebo)
n=24 Participants
Participants were administered LY2216684, albuterol, or placebo during Periods 1, 2, and 3.
LY2216684 or placebo was administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 of each period.
Albuterol or placebo was co-administered as a 2-mg oral dose (one 2-mg tablet) QD on Days 1, 3, and 5 of each period.
|
Group 2, Any Sequence (LY2216684, Propranolol, or Placebo)
n=24 Participants
Participants were administered LY2216684, propranolol, or placebo during Periods 1, 2, and 3.
LY2216684 or placebo was administered as an 18-milligram (mg) oral dose (two 9-mg tablets) QD on Days 1 through 5 of each period.
Propranolol or placebo was co-administered as a 40-mg oral dose (one 40-mg tablet) QD on Days 1, 3, and 5 of each period.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 12.0 • n=99 Participants
|
36.3 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
35.9 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
26.10 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.40 • n=99 Participants
|
28.04 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.33 • n=107 Participants
|
27.07 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.47 • n=206 Participants
|
PRIMARY outcome
Timeframe: Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 10 minutes through 24 hours postdose)Population: Randomized participants with at least 1 postdose heart rate measurement.
Using a Holter monitor, heart rate was recorded every 10 minutes through 24 hours postdose on Days 1, 3, and 5 of each period. Baseline heart rate was the average of 10-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose heart rate was summarized over 1-hour increments using the average of the 10-minute readings within these intervals. The postdose heart rate for a day was the average heart rate for 24 hours. The least squares (LS) mean change from baseline heart rate is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.
Outcome measures
| Measure |
LY2216684 (Group 1)
n=24 Participants
Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Albuterol
n=24 Participants
Participants randomized to Group 1 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Albuterol
n=24 Participants
Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684 (Group 2)
n=22 Participants
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Propranolol
n=22 Participants
Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Propranolol
n=22 Participants
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
|---|---|---|---|---|---|---|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 1 Maximum Change
|
33.4 beats per minute (bpm)
Interval 29.6 to 37.2
|
15.7 beats per minute (bpm)
Interval 11.9 to 19.5
|
35.7 beats per minute (bpm)
Interval 31.9 to 39.5
|
31.1 beats per minute (bpm)
Interval 28.1 to 34.1
|
9.41 beats per minute (bpm)
Interval 6.4 to 12.4
|
17.2 beats per minute (bpm)
Interval 14.2 to 20.2
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 1 Minimum Change
|
-9.23 beats per minute (bpm)
Interval -11.4 to -7.05
|
-15.2 beats per minute (bpm)
Interval -17.4 to -13.0
|
-9.03 beats per minute (bpm)
Interval -11.2 to -6.86
|
-5.81 beats per minute (bpm)
Interval -7.97 to -3.65
|
-14.8 beats per minute (bpm)
Interval -17.0 to -12.6
|
-10.4 beats per minute (bpm)
Interval -12.6 to -8.27
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 1 Average Change
|
9.33 beats per minute (bpm)
Interval 7.08 to 11.6
|
-0.788 beats per minute (bpm)
Interval -3.03 to 1.46
|
10.9 beats per minute (bpm)
Interval 8.64 to 13.1
|
9.55 beats per minute (bpm)
Interval 7.5 to 11.6
|
-3.94 beats per minute (bpm)
Interval -6.0 to -1.89
|
1.11 beats per minute (bpm)
Interval -0.934 to 3.16
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 3 Maximum Change
|
36.3 beats per minute (bpm)
Interval 32.1 to 40.4
|
19.7 beats per minute (bpm)
Interval 15.6 to 23.7
|
37.2 beats per minute (bpm)
Interval 33.0 to 41.3
|
37.2 beats per minute (bpm)
Interval 34.0 to 40.5
|
15.2 beats per minute (bpm)
Interval 12.0 to 18.4
|
27.3 beats per minute (bpm)
Interval 24.1 to 30.5
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 3 Minimum Change
|
-7.05 beats per minute (bpm)
Interval -9.95 to -4.15
|
-16.3 beats per minute (bpm)
Interval -19.1 to -13.4
|
-9.76 beats per minute (bpm)
Interval -12.7 to -6.86
|
-5.94 beats per minute (bpm)
Interval -8.45 to -3.42
|
-16.1 beats per minute (bpm)
Interval -18.6 to -13.6
|
-9.40 beats per minute (bpm)
Interval -11.9 to -6.89
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 3 Average Change
|
12.6 beats per minute (bpm)
Interval 9.82 to 15.5
|
0.102 beats per minute (bpm)
Interval -2.66 to 2.87
|
14.3 beats per minute (bpm)
Interval 11.5 to 17.1
|
14.2 beats per minute (bpm)
Interval 11.9 to 16.5
|
-4.34 beats per minute (bpm)
Interval -6.65 to -2.03
|
6.01 beats per minute (bpm)
Interval 3.71 to 8.31
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 5 Maximum Change
|
40.4 beats per minute (bpm)
Interval 35.8 to 45.0
|
19.9 beats per minute (bpm)
Interval 15.5 to 24.3
|
39.3 beats per minute (bpm)
Interval 34.9 to 43.8
|
36.9 beats per minute (bpm)
Interval 33.5 to 40.3
|
14.0 beats per minute (bpm)
Interval 10.6 to 17.4
|
26.3 beats per minute (bpm)
Interval 22.9 to 29.7
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 5 Minimum Change
|
-9.47 beats per minute (bpm)
Interval -12.1 to -6.81
|
-16.3 beats per minute (bpm)
Interval -18.9 to -13.8
|
-7.27 beats per minute (bpm)
Interval -9.88 to -4.66
|
-5.21 beats per minute (bpm)
Interval -8.19 to -2.23
|
-15.4 beats per minute (bpm)
Interval -18.4 to -12.4
|
-9.46 beats per minute (bpm)
Interval -12.4 to -6.48
|
|
Maximum, Minimum and Average Changes in Heart Rate
Day 5 Average Change
|
14.6 beats per minute (bpm)
Interval 11.6 to 17.5
|
1.05 beats per minute (bpm)
Interval -1.79 to 3.89
|
15.7 beats per minute (bpm)
Interval 12.8 to 18.6
|
15.0 beats per minute (bpm)
Interval 12.4 to 17.6
|
-3.65 beats per minute (bpm)
Interval -6.27 to -1.03
|
6.25 beats per minute (bpm)
Interval 3.64 to 8.86
|
SECONDARY outcome
Timeframe: Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours)Population: Randomized participants with at least 1 postdose systolic blood pressure measurement.
Systolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline systolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose systolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose systolic blood pressure for a day was the average systolic blood pressure for 24 hours. The least squares (LS) mean change from baseline systolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.
Outcome measures
| Measure |
LY2216684 (Group 1)
n=24 Participants
Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Albuterol
n=23 Participants
Participants randomized to Group 1 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Albuterol
n=24 Participants
Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684 (Group 2)
n=22 Participants
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Propranolol
n=22 Participants
Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Propranolol
n=22 Participants
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
|---|---|---|---|---|---|---|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 3 Minimum Change
|
-19.4 millimeters of mercury (mm Hg)
Interval -22.3 to -16.5
|
-24.9 millimeters of mercury (mm Hg)
Interval -27.8 to -22.0
|
-20.6 millimeters of mercury (mm Hg)
Interval -23.4 to -17.7
|
-18.5 millimeters of mercury (mm Hg)
Interval -21.7 to -15.3
|
-27.2 millimeters of mercury (mm Hg)
Interval -30.4 to -24.0
|
-23.3 millimeters of mercury (mm Hg)
Interval -26.5 to -20.0
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 3 Average Change
|
-1.65 millimeters of mercury (mm Hg)
Interval -4.07 to 0.762
|
-1.87 millimeters of mercury (mm Hg)
Interval -4.29 to 0.548
|
-1.99 millimeters of mercury (mm Hg)
Interval -4.35 to 0.375
|
0.289 millimeters of mercury (mm Hg)
Interval -2.35 to 2.93
|
-8.75 millimeters of mercury (mm Hg)
Interval -11.4 to -6.1
|
-3.91 millimeters of mercury (mm Hg)
Interval -6.6 to -1.21
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 5 Maximum Change
|
13.9 millimeters of mercury (mm Hg)
Interval 10.4 to 17.3
|
15.9 millimeters of mercury (mm Hg)
Interval 12.5 to 19.4
|
16.2 millimeters of mercury (mm Hg)
Interval 12.9 to 19.6
|
14.7 millimeters of mercury (mm Hg)
Interval 11.3 to 18.0
|
11.1 millimeters of mercury (mm Hg)
Interval 7.72 to 14.5
|
13.1 millimeters of mercury (mm Hg)
Interval 9.69 to 16.4
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 1 Maximum Change
|
14.1 millimeters of mercury (mm Hg)
Interval 11.9 to 16.4
|
15.2 millimeters of mercury (mm Hg)
Interval 12.9 to 17.5
|
15.8 millimeters of mercury (mm Hg)
Interval 13.5 to 18.0
|
17.3 millimeters of mercury (mm Hg)
Interval 14.3 to 20.3
|
9.39 millimeters of mercury (mm Hg)
Interval 6.39 to 12.4
|
10.9 millimeters of mercury (mm Hg)
Interval 7.87 to 13.8
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 1 Minimum Change
|
-18.0 millimeters of mercury (mm Hg)
Interval -20.8 to -15.2
|
-20.5 millimeters of mercury (mm Hg)
Interval -23.4 to -17.7
|
-15.3 millimeters of mercury (mm Hg)
Interval -18.1 to -12.5
|
-17.7 millimeters of mercury (mm Hg)
Interval -21.3 to -14.2
|
-29.0 millimeters of mercury (mm Hg)
Interval -32.5 to -25.4
|
-17.5 millimeters of mercury (mm Hg)
Interval -21.1 to -14.0
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 1 Average Change
|
-0.986 millimeters of mercury (mm Hg)
Interval -2.97 to 0.995
|
-0.912 millimeters of mercury (mm Hg)
Interval -2.93 to 1.11
|
1.69 millimeters of mercury (mm Hg)
Interval -0.292 to 3.67
|
1.73 millimeters of mercury (mm Hg)
Interval -0.508 to 3.97
|
-8.50 millimeters of mercury (mm Hg)
Interval -10.7 to -6.25
|
-1.35 millimeters of mercury (mm Hg)
Interval -3.59 to 0.884
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 3 Maximum Change
|
13.5 millimeters of mercury (mm Hg)
Interval 9.99 to 16.9
|
15.6 millimeters of mercury (mm Hg)
Interval 12.1 to 19.1
|
13.5 millimeters of mercury (mm Hg)
Interval 10.1 to 16.9
|
15.3 millimeters of mercury (mm Hg)
Interval 12.1 to 18.6
|
7.99 millimeters of mercury (mm Hg)
Interval 4.74 to 11.2
|
11.2 millimeters of mercury (mm Hg)
Interval 7.89 to 14.5
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 5 Minimum Change
|
-20.8 millimeters of mercury (mm Hg)
Interval -24.0 to -17.6
|
-22.1 millimeters of mercury (mm Hg)
Interval -25.3 to -18.9
|
-18.9 millimeters of mercury (mm Hg)
Interval -22.0 to -15.8
|
-21.1 millimeters of mercury (mm Hg)
Interval -24.5 to -17.6
|
-24.9 millimeters of mercury (mm Hg)
Interval -28.3 to -21.5
|
-21.2 millimeters of mercury (mm Hg)
Interval -24.6 to -17.8
|
|
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Day 5 Average Change
|
-2.07 millimeters of mercury (mm Hg)
Interval -4.4 to 0.27
|
-2.36 millimeters of mercury (mm Hg)
Interval -4.69 to -0.0204
|
-0.233 millimeters of mercury (mm Hg)
Interval -2.52 to 2.05
|
-1.72 millimeters of mercury (mm Hg)
Interval -4.3 to 0.865
|
-6.83 millimeters of mercury (mm Hg)
Interval -9.42 to -4.24
|
-2.55 millimeters of mercury (mm Hg)
Interval -5.13 to 0.0363
|
SECONDARY outcome
Timeframe: Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours)Population: Randomized participants with at least 1 postdose diastolic blood pressure measurement.
Diastolic blood pressure was measured using ambulatory blood pressure monitoring (ABPM) recorded every 15 minutes during the daytime (0600 through 2200 hours) and every hour throughout the night time (2200 through 0600 hours) on Days 1, 3, and 5 of each period. Baseline diastolic blood pressure was the average of 15-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose diastolic blood pressure from ABPM was summarized over 1-hour increments using the average of the 15-minute readings within these intervals. The postdose diastolic blood pressure for a day was the average diastolic blood pressure for 24 hours. The least squares (LS) mean change from baseline diastolic blood pressure is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.
Outcome measures
| Measure |
LY2216684 (Group 1)
n=24 Participants
Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Albuterol
n=23 Participants
Participants randomized to Group 1 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Albuterol
n=24 Participants
Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684 (Group 2)
n=22 Participants
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Propranolol
n=22 Participants
Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Propranolol
n=22 Participants
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
|---|---|---|---|---|---|---|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 1 Average Change
|
-0.674 millimeters of mercury (mm Hg)
Interval -2.38 to 1.03
|
-3.27 millimeters of mercury (mm Hg)
Interval -5.01 to -1.53
|
-0.873 millimeters of mercury (mm Hg)
Interval -2.58 to 0.833
|
0.481 millimeters of mercury (mm Hg)
Interval -1.37 to 2.33
|
-7.47 millimeters of mercury (mm Hg)
Interval -9.33 to -5.61
|
-1.44 millimeters of mercury (mm Hg)
Interval -3.29 to 0.41
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 3 Maximum Change
|
13.6 millimeters of mercury (mm Hg)
Interval 11.4 to 15.9
|
11.8 millimeters of mercury (mm Hg)
Interval 9.6 to 14.1
|
12.7 millimeters of mercury (mm Hg)
Interval 10.5 to 14.9
|
15.4 millimeters of mercury (mm Hg)
Interval 13.0 to 17.7
|
6.87 millimeters of mercury (mm Hg)
Interval 4.51 to 9.24
|
12.5 millimeters of mercury (mm Hg)
Interval 10.1 to 14.9
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 3 Minimum Change
|
-18.1 millimeters of mercury (mm Hg)
Interval -21.0 to -15.3
|
-21.5 millimeters of mercury (mm Hg)
Interval -24.3 to -18.7
|
-18.6 millimeters of mercury (mm Hg)
Interval -21.4 to -15.8
|
-17.8 millimeters of mercury (mm Hg)
Interval -20.5 to -15.2
|
-26.6 millimeters of mercury (mm Hg)
Interval -29.3 to -24.0
|
-18.8 millimeters of mercury (mm Hg)
Interval -21.5 to -16.1
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 3 Average Change
|
-0.537 millimeters of mercury (mm Hg)
Interval -2.24 to 1.17
|
-3.10 millimeters of mercury (mm Hg)
Interval -4.8 to -1.4
|
-0.159 millimeters of mercury (mm Hg)
Interval -1.83 to 1.51
|
0.619 millimeters of mercury (mm Hg)
Interval -1.44 to 2.68
|
-7.80 millimeters of mercury (mm Hg)
Interval -9.87 to -5.74
|
-1.20 millimeters of mercury (mm Hg)
Interval -3.31 to 0.9
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 1 Maximum Change
|
13.4 millimeters of mercury (mm Hg)
Interval 11.7 to 15.2
|
10.8 millimeters of mercury (mm Hg)
Interval 9.05 to 12.6
|
12.2 millimeters of mercury (mm Hg)
Interval 10.5 to 13.9
|
14.9 millimeters of mercury (mm Hg)
Interval 12.6 to 17.1
|
8.16 millimeters of mercury (mm Hg)
Interval 5.88 to 10.4
|
10.6 millimeters of mercury (mm Hg)
Interval 8.37 to 12.9
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 1 Minimum Change
|
-17.3 millimeters of mercury (mm Hg)
Interval -19.4 to -15.1
|
-19.9 millimeters of mercury (mm Hg)
Interval -22.1 to -17.7
|
-16.2 millimeters of mercury (mm Hg)
Interval -18.4 to -14.1
|
-17.9 millimeters of mercury (mm Hg)
Interval -21.2 to -14.6
|
-26.7 millimeters of mercury (mm Hg)
Interval -30.0 to -23.4
|
-17.6 millimeters of mercury (mm Hg)
Interval -20.9 to -14.3
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 5 Maximum Change
|
13.8 millimeters of mercury (mm Hg)
Interval 11.3 to 16.4
|
12.8 millimeters of mercury (mm Hg)
Interval 10.2 to 15.3
|
14.7 millimeters of mercury (mm Hg)
Interval 12.2 to 17.2
|
13.1 millimeters of mercury (mm Hg)
Interval 10.2 to 16.0
|
6.58 millimeters of mercury (mm Hg)
Interval 3.69 to 9.47
|
13.8 millimeters of mercury (mm Hg)
Interval 11.0 to 16.7
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 5 Minimum Change
|
-17.0 millimeters of mercury (mm Hg)
Interval -20.2 to -13.8
|
-21.6 millimeters of mercury (mm Hg)
Interval -24.8 to -18.4
|
-20.5 millimeters of mercury (mm Hg)
Interval -23.7 to -17.3
|
-19.1 millimeters of mercury (mm Hg)
Interval -22.2 to -15.9
|
-26.6 millimeters of mercury (mm Hg)
Interval -29.7 to -23.4
|
-21.0 millimeters of mercury (mm Hg)
Interval -24.2 to -17.8
|
|
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Day 5 Average
|
0.233 millimeters of mercury (mm Hg)
Interval -1.74 to 2.2
|
-3.17 millimeters of mercury (mm Hg)
Interval -5.14 to -1.2
|
-0.140 millimeters of mercury (mm Hg)
Interval -2.08 to 1.8
|
-0.631 millimeters of mercury (mm Hg)
Interval -2.81 to 1.55
|
-7.33 millimeters of mercury (mm Hg)
Interval -9.52 to -5.14
|
-1.80 millimeters of mercury (mm Hg)
Interval -3.99 to 0.381
|
Adverse Events
LY2216684 (Group 1)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Albuterol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY2216684+Albuterol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LY2216684 (Group 2)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Propranolol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2216684+Propranolol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2216684 (Group 1)
n=24 participants at risk
Participants randomized to Group 1 who received LY2216684 administered as an 18-milligram (mg) oral dose (two 9-mg tablets) once daily (QD) on Days 1 through 5 with single oral doses of placebo (for albuterol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Albuterol
n=24 participants at risk
Participants randomized to Group 1 who received who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Albuterol
n=24 participants at risk
Participants randomized to Group 1 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 2 mg albuterol (one 2-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684 (Group 2)
n=22 participants at risk
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of placebo (for propranolol) co-administered on Days 1, 3, and 5 in any treatment period.
|
Propranolol
n=22 participants at risk
Participants randomized to Group 2 who received oral doses of placebo (for LY2216684) administered QD on Days 1 through 5 with single oral doses of 40-mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
LY2216684+Propranolol
n=22 participants at risk
Participants randomized to Group 2 who received LY2216684 administered as an 18-mg oral dose (two 9-mg tablets) QD on Days 1 through 5 with single oral doses of 40 mg propranolol (one 40-mg tablet) co-administered on Days 1, 3, and 5 in any treatment period.
|
|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Scrotal pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/13
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/17
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
General disorders
Chills
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
9.1%
2/22 • Number of events 2
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
Chapped lips
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
20.8%
5/24 • Number of events 5
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
13.6%
3/22 • Number of events 3
|
0.00%
0/22
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
General disorders
Application site irritation
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Chest pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
General disorders
Fatigue
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
General disorders
Feeling hot
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Irritability
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Infections and infestations
Carbuncle
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 2
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
0.00%
0/22
|
13.6%
3/22 • Number of events 3
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
9.1%
2/22 • Number of events 2
|
0.00%
0/22
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Psychiatric disorders
Agitation
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Psychiatric disorders
Depression
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
9.1%
2/22 • Number of events 2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Genital pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/17
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/13
|
|
Reproductive system and breast disorders
Penile size reduced
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
4/24 • Number of events 5
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Vascular disorders
Flushing
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
|
Vascular disorders
Hot flush
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
0.00%
0/22
|
9.1%
2/22 • Number of events 2
|
|
Vascular disorders
Peripheral coldness
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
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