Trial Outcomes & Findings for A Study of LY3016859 in Healthy Volunteers (NCT NCT01545583)
NCT ID: NCT01545583
Last Updated: 2018-07-19
Results Overview
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
From baseline up to 8 weeks post dose
Results posted on
2018-07-19
Participant Flow
Participant milestones
| Measure |
Placebo IV
Placebo administered once intravenously (IV).
|
Placebo SC
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
2
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
12
|
2
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
2
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3016859 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
10 mg LY3016859 IV
n=6 Participants
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=6 Participants
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=6 Participants
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
n=6 Participants
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
n=6 Participants
50 mg LY3016859 administered once subcutaneously.
|
Total
n=56 Participants
Total of all reporting groups
|
Placebo IV
n=12 Participants
Placebo administered once intravenously (IV).
|
Placebo SC
n=2 Participants
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 Participants
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 Participants
1 mg LY3016859 administered once intravenously.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 8.59 • n=21 Participants
|
43.2 years
STANDARD_DEVIATION 17.42 • n=8 Participants
|
41.3 years
STANDARD_DEVIATION 17.25 • n=8 Participants
|
47.0 years
STANDARD_DEVIATION 14.68 • n=24 Participants
|
33.0 years
STANDARD_DEVIATION 11.68 • n=42 Participants
|
35.3 years
STANDARD_DEVIATION 13.02 • n=42 Participants
|
29.8 years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 11.31 • n=7 Participants
|
29.7 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 9.71 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
2 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
6 participants
n=8 Participants
|
6 participants
n=24 Participants
|
6 participants
n=42 Participants
|
56 participants
n=42 Participants
|
12 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 8 weeks post dosePopulation: All randomized participants who received at least one dose of study drug.
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Outcome measures
| Measure |
Placebo IV
n=12 Participants
Placebo administered once intravenously (IV).
|
Placebo SC
n=2 Participants
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 Participants
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 Participants
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
n=6 Participants
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=6 Participants
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=6 Participants
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
n=6 Participants
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
n=6 Participants
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)
TEAE
|
2 participants
|
0 participants
|
2 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)
SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose up to 8 weeks post dosePopulation: All randomized participants who received at least one dose of study drug and had TGFα measurements.
Outcome measures
| Measure |
Placebo IV
n=12 Participants
Placebo administered once intravenously (IV).
|
Placebo SC
n=2 Participants
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 Participants
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 Participants
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
n=6 Participants
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=6 Participants
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=6 Participants
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
n=6 Participants
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
n=6 Participants
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)
|
41271 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 109300.8
|
8573 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 5072.1
|
2515 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 2340.0
|
4444 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 4234.6
|
9718 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 9089.5
|
4286 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 2578.9
|
8244 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 6487.5
|
12075 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 17137.0
|
10305 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 7555.2
|
SECONDARY outcome
Timeframe: Predose up to 8 weeks post dosePopulation: All randomized participants who received at least one dose of study drug and had serum epiregulin measurements.
Outcome measures
| Measure |
Placebo IV
n=12 Participants
Placebo administered once intravenously (IV).
|
Placebo SC
n=2 Participants
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 Participants
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 Participants
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
n=6 Participants
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=6 Participants
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=6 Participants
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
n=6 Participants
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
n=6 Participants
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin
|
349927 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 118584.0
|
331408 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 52233.4
|
280500 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 65395.6
|
296022 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 94056.4
|
405745 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 76219.5
|
379401 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 59460.6
|
697442 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 229112.6
|
2254733 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 1035876.0
|
474081 hour*picograms/milliliter (h*pg/mL)
Standard Deviation 280526.0
|
SECONDARY outcome
Timeframe: Predose up to 8 weeks post dosePopulation: All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to estimate Cmax.
Outcome measures
| Measure |
Placebo IV
n=5 Participants
Placebo administered once intravenously (IV).
|
Placebo SC
n=6 Participants
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 Participants
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 Participants
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
n=6 Participants
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=6 Participants
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=6 Participants
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859
|
36 nanograms/milliliter (ng/mL)
Standard Deviation 4.3
|
399 nanograms/milliliter (ng/mL)
Standard Deviation 95.6
|
3812 nanograms/milliliter (ng/mL)
Standard Deviation 718.3
|
18467 nanograms/milliliter (ng/mL)
Standard Deviation 1882.2
|
106967 nanograms/milliliter (ng/mL)
Standard Deviation 20038.0
|
271167 nanograms/milliliter (ng/mL)
Standard Deviation 59650.4
|
3748 nanograms/milliliter (ng/mL)
Standard Deviation 1550.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 8 weeks post dosePopulation: All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to calculate AUC0-inf.
Outcome measures
| Measure |
Placebo IV
Placebo administered once intravenously (IV).
|
Placebo SC
n=3 Participants
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 Participants
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 Participants
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
n=6 Participants
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=5 Participants
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=5 Participants
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)
|
—
|
9967 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 2375.4
|
235759 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 46760.1
|
2769626 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 516303.9
|
23180633 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 9009921.3
|
81450520 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 20101546.7
|
1054034 hour*nanograms/milliliter (h*ng/mL)
Standard Deviation 536160.4
|
—
|
—
|
Adverse Events
Placebo IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.1 mg LY3016859 IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1 mg LY3016859 IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10 mg LY3016859 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
50 mg LY3016859 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
250 mg LY3016859 IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
750 mg LY3016859 IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg LY3016859 SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo IV
n=12 participants at risk
Placebo administered once intravenously (IV).
|
Placebo SC
n=2 participants at risk
Placebo administered once subcutaneously (SC).
|
0.1 mg LY3016859 IV
n=6 participants at risk
0.1 milligram (mg) LY3016859 administered once intravenously.
|
1 mg LY3016859 IV
n=6 participants at risk
1 mg LY3016859 administered once intravenously.
|
10 mg LY3016859 IV
n=6 participants at risk
10 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 IV
n=6 participants at risk
50 mg LY3016859 administered once intravenously.
|
250 mg LY3016859 IV
n=6 participants at risk
250 mg LY3016859 administered once intravenously.
|
750 mg LY3016859 IV
n=6 participants at risk
750 mg LY3016859 administered once intravenously.
|
50 mg LY3016859 SC
n=6 participants at risk
50 mg LY3016859 administered once subcutaneously.
|
|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Dry eyes
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 3
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Feeling cold
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Feeling hot
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 5
|
50.0%
1/2 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12
|
0.00%
0/2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12
|
0.00%
0/2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
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