Trial Outcomes & Findings for Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance (NCT NCT01237899)
NCT ID: NCT01237899
Last Updated: 2019-06-03
Results Overview
A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline through 7 days for each treatment period
Results posted on
2019-06-03
Participant Flow
Participant milestones
| Measure |
1 mg LY2623091 First Then 25 mg LY2623091
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
1 mg LY2623091 First Then Placebo
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
1 mg LY2623091 First Then 50 mg Eplerenone
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
|
50 mg Eplerenone First Then 25 mg LY2623091
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
50 mg Eplerenone First Then Placebo
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
Placebo First Then 25 mg LY2623091
Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
10 mg LY2623091 First Then 0.3 mg LY2623091
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before 0.3 mg LY2623091 daily by mouth for 7 days.
|
10 mg LY2623091 First Then Placebo
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
10 mg LY2623091 First Then 50 mg Eplerenone
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
|
50 mg Eplerenone First Then 0.3 mg LY2623091
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
|
Placebo Then 0.3 mg LY2623091
Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Dosing Period
STARTED
|
1
|
3
|
4
|
3
|
2
|
4
|
1
|
3
|
4
|
3
|
4
|
|
First Dosing Period
COMPLETED
|
1
|
3
|
4
|
3
|
2
|
4
|
1
|
3
|
4
|
3
|
4
|
|
First Dosing Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period of at Least 7 Days
STARTED
|
1
|
3
|
4
|
3
|
2
|
4
|
1
|
3
|
4
|
3
|
4
|
|
Washout Period of at Least 7 Days
COMPLETED
|
1
|
3
|
3
|
3
|
2
|
4
|
1
|
3
|
4
|
3
|
4
|
|
Washout Period of at Least 7 Days
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Dosing Period
STARTED
|
1
|
3
|
3
|
3
|
2
|
4
|
1
|
3
|
4
|
3
|
4
|
|
Second Dosing Period
COMPLETED
|
1
|
3
|
3
|
3
|
2
|
4
|
1
|
3
|
4
|
3
|
4
|
|
Second Dosing Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
1 mg LY2623091 First Then 25 mg LY2623091
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
1 mg LY2623091 First Then Placebo
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
1 mg LY2623091 First Then 50 mg Eplerenone
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
|
50 mg Eplerenone First Then 25 mg LY2623091
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
50 mg Eplerenone First Then Placebo
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
Placebo First Then 25 mg LY2623091
Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
10 mg LY2623091 First Then 0.3 mg LY2623091
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before 0.3 mg LY2623091 daily by mouth for 7 days.
|
10 mg LY2623091 First Then Placebo
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
10 mg LY2623091 First Then 50 mg Eplerenone
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
|
50 mg Eplerenone First Then 0.3 mg LY2623091
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
|
Placebo Then 0.3 mg LY2623091
Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Washout Period of at Least 7 Days
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance
Baseline characteristics by cohort
| Measure |
1 mg LY2623091 First Then 25 mg LY2623091
n=1 Participants
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
1 mg LY2623091 First Then Placebo
n=3 Participants
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
1 mg LY2623091 First Then 50 mg Eplerenone
n=4 Participants
1 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
|
50 mg Eplerenone First Then 25 mg LY2623091
n=3 Participants
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
50 mg Eplerenone First Then Placebo
n=2 Participants
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
Placebo First Then 25 mg LY2623091
n=4 Participants
Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 25 mg LY2623091 daily by mouth for 7 days.
|
10 mg LY2623091 First Then 0.3 mg LY2623091
n=1 Participants
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before 0.3 mg LY2623091 daily by mouth for 7 days.
|
10 mg LY2623091 First Then Placebo
n=3 Participants
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving placebo daily by mouth for 7 days.
|
10 mg LY2623091 First Then 50 mg Eplerenone
n=4 Participants
10 mg LY2623091 daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 50 mg eplerenone daily by mouth for 7 days.
|
50 mg Eplerenone First Then 0.3 mg LY2623091
n=3 Participants
50 mg eplerenone daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
|
Placebo Then 0.3 mg LY2623091
n=4 Participants
Placebo daily by mouth for 7 days, followed by a minimum 7-day washout period before receiving 0.3 mg LY2623091 daily by mouth for 7 days.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
32 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through 7 days for each treatment periodPopulation: All participants who received at least 1 dose of study drug.
A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Outcome measures
| Measure |
Placebo
n=16 Participants
Daily by mouth for 7 days.
|
0.3 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
1 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
10 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
25 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
50 mg Eplerenone
n=15 Participants
Daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects (Adverse Events)
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Effects (Adverse Events)
Nonserious Adverse Events
|
6 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 7: 24 Hour (hr), 48hr and 72hr PostdosePopulation: All participants who received at least 1 dose of study drug and for whom the data are considered sufficient and interpretable.
A measure of the renal clearance of the potassium ion (K+). The Least Squares (LS) Mean value was adjusted for pre-challenge renal K+ clearance.
Outcome measures
| Measure |
Placebo
n=16 Participants
Daily by mouth for 7 days.
|
0.3 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
1 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
10 mg LY2623091
n=7 Participants
Daily by mouth for 7 days.
|
25 mg LY2623091
n=6 Participants
Daily by mouth for 7 days.
|
50 mg Eplerenone
n=15 Participants
Daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Serum to Urine Potassium Area Under the Concentration-Time Curve (AUC) Standardized for Urinary Excretion at Day 7
|
2.098 liter per hour (L/h)
Interval 1.93 to 2.281
|
1.940 liter per hour (L/h)
Interval 1.748 to 2.153
|
1.981 liter per hour (L/h)
Interval 1.781 to 2.204
|
1.788 liter per hour (L/h)
Interval 1.602 to 1.995
|
1.551 liter per hour (L/h)
Interval 1.383 to 1.739
|
1.838 liter per hour (L/h)
Interval 1.687 to 2.002
|
SECONDARY outcome
Timeframe: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr PostdosePopulation: All participants who received at least 1 dose of study drug and for whom the data are considered sufficient and interpretable.
Cmax estimated for LY2623091.
Outcome measures
| Measure |
Placebo
n=8 Participants
Daily by mouth for 7 days.
|
0.3 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
1 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
10 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
25 mg LY2623091
Daily by mouth for 7 days.
|
50 mg Eplerenone
Daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics of LY2623091: Maximal Concentration (Cmax) at Day 6
|
7.57 nanograms per milliliter (ng/mL)
Standard Deviation 0.776
|
27.5 nanograms per milliliter (ng/mL)
Standard Deviation 5.19
|
324 nanograms per milliliter (ng/mL)
Standard Deviation 55.2
|
812 nanograms per milliliter (ng/mL)
Standard Deviation 106
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr PostdosePopulation: All participants who received at least 1 dose of study drug and for whom the data are considered sufficient and interpretable.
AUC from time 0, extrapolated to infinity, estimated for LY2623091.
Outcome measures
| Measure |
Placebo
n=8 Participants
Daily by mouth for 7 days.
|
0.3 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
1 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
10 mg LY2623091
n=8 Participants
Daily by mouth for 7 days.
|
25 mg LY2623091
Daily by mouth for 7 days.
|
50 mg Eplerenone
Daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics LY2623091: Area Under the Concentration-Time Curve (AUC) at Day 6
|
0.123 microgram*hour per milliliter (µg*h/mL)
Standard Deviation 0.0141
|
0.444 microgram*hour per milliliter (µg*h/mL)
Standard Deviation 0.0741
|
5.50 microgram*hour per milliliter (µg*h/mL)
Standard Deviation 1.08
|
13.7 microgram*hour per milliliter (µg*h/mL)
Standard Deviation 2.37
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.3 mg LY2623091
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1 mg LY2623091
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
10 mg LY2623091
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
25 mg LY2623091
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg Eplerenone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Daily by mouth for 7 days.
|
0.3 mg LY2623091
n=8 participants at risk
Daily by mouth for 7 days.
|
1 mg LY2623091
n=8 participants at risk
Daily by mouth for 7 days.
|
10 mg LY2623091
n=8 participants at risk
Daily by mouth for 7 days.
|
25 mg LY2623091
n=8 participants at risk
Daily by mouth for 7 days.
|
50 mg Eplerenone
n=15 participants at risk
Daily by mouth for 7 days.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/16
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Lip dry
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
General disorders
Application site irritation
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Catheter site related reaction
|
12.5%
2/16 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/16
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 2
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
20.0%
3/15 • Number of events 3
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/16
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
33.3%
5/15 • Number of events 6
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/16
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
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