Trial Outcomes & Findings for A Study of LY2951742 in Healthy Volunteers (NCT NCT01337596)
NCT ID: NCT01337596
Last Updated: 2019-02-20
Results Overview
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Baseline up to 6 months (study completion)
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
1 mg Single Dose LY2951742
Single dose 1 milligram (mg) LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
7
|
7
|
7
|
12
|
2
|
7
|
|
Overall Study
Safety Population
|
7
|
7
|
7
|
7
|
7
|
7
|
12
|
2
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
7
|
5
|
7
|
12
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
1 mg Single Dose LY2951742
Single dose 1 milligram (mg) LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2951742 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
1 mg Single Dose LY2951742
n=7 Participants
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
n=7 Participants
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
n=7 Participants
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
n=7 Participants
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
n=7 Participants
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
n=7 Participants
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
n=12 Participants
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
n=2 Participants
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
n=7 Participants
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
29.0 years
STANDARD_DEVIATION 7.5 • n=107 Participants
|
31.9 years
STANDARD_DEVIATION 14.3 • n=206 Participants
|
30.9 years
STANDARD_DEVIATION 10.5 • n=157 Participants
|
37.0 years
STANDARD_DEVIATION 14.6 • n=390 Participants
|
33.9 years
STANDARD_DEVIATION 13.9 • n=16 Participants
|
30.8 years
STANDARD_DEVIATION 10.0 • n=3 Participants
|
22.5 years
STANDARD_DEVIATION 0.7 • n=6 Participants
|
22.4 years
STANDARD_DEVIATION 1.6 • n=114 Participants
|
30.2 years
STANDARD_DEVIATION 11.1 • n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
7 Participants
n=16 Participants
|
12 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
63 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=157 Participants
|
7 participants
n=390 Participants
|
7 participants
n=16 Participants
|
12 participants
n=3 Participants
|
2 participants
n=6 Participants
|
7 participants
n=114 Participants
|
63 participants
n=23 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=157 Participants
|
7 participants
n=390 Participants
|
7 participants
n=16 Participants
|
12 participants
n=3 Participants
|
2 participants
n=6 Participants
|
7 participants
n=114 Participants
|
63 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 months (study completion)Population: Safety Population: All participants who received at least 1 dose of the study drug.
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1 Milligram (mg) Single Dose LY2951742
n=7 Participants
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
n=7 Participants
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
n=7 Participants
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
n=7 Participants
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
n=7 Participants
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
n=7 Participants
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
n=12 Participants
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
n=2 Participants
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
n=7 Participants
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Effects
Other Non-Serious Adverse Events
|
6 participants
|
5 participants
|
7 participants
|
4 participants
|
7 participants
|
5 participants
|
9 participants
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 84 or early discontinuationPopulation: Pharmacokinetic (PK) Population: All participants who received single dose LY2951742 study drug with interpretable PK data.
Outcome measures
| Measure |
1 Milligram (mg) Single Dose LY2951742
n=7 Participants
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
n=7 Participants
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
n=7 Participants
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
n=7 Participants
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
n=7 Participants
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
n=7 Participants
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
|
95.60 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.26
|
404.61 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.45
|
1995.35 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44.48
|
5920.79 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48.51
|
13750.14 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.72
|
45039.42 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 84 or early discontinuationPopulation: PK Population: All participants who received single dose LY2951742 study drug with interpretable PK data.
Outcome measures
| Measure |
1 Milligram (mg) Single Dose LY2951742
n=7 Participants
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
n=7 Participants
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
n=7 Participants
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
n=7 Participants
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
n=7 Participants
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
n=7 Participants
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
|
4718.4 nanogram*day per milliliter (ng*day/mL)
Geometric Coefficient of Variation 11.6
|
19743.5 nanogram*day per milliliter (ng*day/mL)
Geometric Coefficient of Variation 29.7
|
92310.1 nanogram*day per milliliter (ng*day/mL)
Geometric Coefficient of Variation 32.7
|
263144.2 nanogram*day per milliliter (ng*day/mL)
Geometric Coefficient of Variation 44.7
|
624419.4 nanogram*day per milliliter (ng*day/mL)
Geometric Coefficient of Variation 39.8
|
2280259.7 nanogram*day per milliliter (ng*day/mL)
Geometric Coefficient of Variation 9.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 43 up to Day 57Population: PK Population: All participants who received multiple doses LY2951742 study drug with interpretable PK data.
Outcome measures
| Measure |
1 Milligram (mg) Single Dose LY2951742
n=7 Participants
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
|
36846.420 ng/mL
Geometric Coefficient of Variation 14.878
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 43 up to Day 57Population: PK Population: All participants who received multiple dose LY2951742 study drug with interpretable PK data.
Outcome measures
| Measure |
1 Milligram (mg) Single Dose LY2951742
n=7 Participants
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
|
1806501.8 ng*day/mL
Geometric Coefficient of Variation 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
1 mg Single Dose LY2951742
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
5 mg Single Dose LY2951742
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
25 mg Single Dose LY2951742
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
75 mg Single Dose LY2951742
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
200 mg Single Dose LY2951742
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
600 mg Single Dose LY2951742
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Single Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Multiple Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
150 mg Multiple Dose LY2951742
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 mg Single Dose LY2951742
n=7 participants at risk
Single dose 1 mg LY2951742 administered subcutaneously.
|
5 mg Single Dose LY2951742
n=7 participants at risk
Single dose 5 mg LY2951742 administered subcutaneously.
|
25 mg Single Dose LY2951742
n=7 participants at risk
Single dose 25 mg LY2951742 administered subcutaneously.
|
75 mg Single Dose LY2951742
n=7 participants at risk
Single dose 75 mg LY2951742 administered subcutaneously.
|
200 mg Single Dose LY2951742
n=7 participants at risk
Single dose 200 mg LY2951742 administered subcutaneously.
|
600 mg Single Dose LY2951742
n=7 participants at risk
Single dose 600 mg LY2951742 administered subcutaneously.
|
Placebo Single Dose
n=12 participants at risk
Single dose matched placebo administered subcutaneously.
|
Placebo Multiple Dose
n=2 participants at risk
Multiple dose matched placebo administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
150 mg Multiple Dose LY2951742
n=7 participants at risk
Multiple dose 150 mg LY2951742 administered subcutaneously every 2 weeks for 6 weeks (4 doses).
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Eye disorders
Accommodation disorder
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Eye disorders
Visual impairment
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Chest discomfort
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Influenza like illness
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Injection site erythema
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Injection site pain
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Mucosal dryness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Nasopharyngitis
|
42.9%
3/7 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
33.3%
4/12 • Number of events 4
|
100.0%
2/2 • Number of events 2
|
57.1%
4/7 • Number of events 4
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Sialoadenitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Blood immunoglobulin e increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Blood sodium decreased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Eosinophil count increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 3
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Heart rate increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness postural
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1
|
42.9%
3/7 • Number of events 3
|
28.6%
2/7 • Number of events 3
|
0.00%
0/7
|
57.1%
4/7 • Number of events 4
|
28.6%
2/7 • Number of events 2
|
41.7%
5/12 • Number of events 5
|
50.0%
1/2 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Nervous system disorders
Tension headache
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
0.00%
0/12
|
50.0%
1/2 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Leukocyturia
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
57.1%
4/7 • Number of events 5
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/7
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/12
|
0.00%
0/2
|
14.3%
1/7 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60