Trial Outcomes & Findings for A Study of LY3050258 in Healthy Participants (NCT NCT02121834)
NCT ID: NCT02121834
Last Updated: 2018-07-27
Results Overview
Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Baseline to Study Completion (Up to 14 Weeks)
Results posted on
2018-07-27
Participant Flow
Participant milestones
| Measure |
Cohort A-D Placebo
Placebo daily for 28 days
|
Cohort A: 10 Milligram (mg) LY3050258
10 mg LY3050258, daily for 28 days
|
Cohort B: 30 mg LY3050258
30mg LY3050258, daily for 28 days
|
Cohort C: 90 mg LY3050258
90 mg LY3050258, daily for 28 days
|
Cohort D: 180 mg LY3050258
180 mg LY3050258, daily for 28 days
|
Cohort E: 360 mg LY3050258
360 mg LY3050258, daily for 28 days
|
Cohort E Placebo
Placebo daily for 28 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
9
|
10
|
9
|
9
|
3
|
|
Overall Study
Received at Least One Dose of Study Drug
|
12
|
11
|
9
|
10
|
9
|
9
|
3
|
|
Overall Study
COMPLETED
|
12
|
9
|
7
|
10
|
9
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A-D Placebo
Placebo daily for 28 days
|
Cohort A: 10 Milligram (mg) LY3050258
10 mg LY3050258, daily for 28 days
|
Cohort B: 30 mg LY3050258
30mg LY3050258, daily for 28 days
|
Cohort C: 90 mg LY3050258
90 mg LY3050258, daily for 28 days
|
Cohort D: 180 mg LY3050258
180 mg LY3050258, daily for 28 days
|
Cohort E: 360 mg LY3050258
360 mg LY3050258, daily for 28 days
|
Cohort E Placebo
Placebo daily for 28 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3050258 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort A-D Placebo
n=12 Participants
Placebo daily for 28 days
|
Cohort A: LY3050258
n=11 Participants
10 mg LY3050258, daily for 28 days
|
Cohort B: LY3050258
n=9 Participants
30 mg LY3050258, daily for 28 days
|
Cohort C: LY3050258
n=10 Participants
90 mg LY3050258, daily for 28 days
|
Cohort D: LY3050258
n=9 Participants
180 mg LY3050258, daily for 28 days
|
Cohort E: LY3050258
n=9 Participants
360 mg LY3050258, daily for 28 days
|
Cohort E Placebo
n=3 Participants
Placebo daily for 28 days
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
14 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
31 Participants
n=40 Participants
|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
50.5 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
51.6 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
52.8 years
STANDARD_DEVIATION 10.4 • n=483 Participants
|
44.6 years
STANDARD_DEVIATION 10.6 • n=36 Participants
|
47.8 years
STANDARD_DEVIATION 10.5 • n=10 Participants
|
35.7 years
STANDARD_DEVIATION 5.5 • n=115 Participants
|
48.7 years
STANDARD_DEVIATION 10.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
42 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
17 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
46 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
63 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (Up to 14 Weeks)Population: All participants who received at least one dose of study drug.
Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo Cohort A-D
n=12 Participants
Placebo daily for 28 days
|
10 mg LY3050258
n=11 Participants
10 mg LY3050258, daily for 28 days
|
30 mg LY3050258
n=9 Participants
30 mg LY3050258, daily for 28 days
|
90 mg LY3050258
n=10 Participants
90 mg LY3050258, daily for 28 days
|
180 mg LY3050258
n=9 Participants
180 mg LY3050258, daily for 28 days
|
360 mg LY3050258
n=9 Participants
360 mg LY3050258, daily for 28 days
|
Placebo Cohort E
n=3 Participants
Placebo daily for 28 days
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrsPopulation: All participants who received at least one dose of study drug and had measurable AUC PK concentrations after dosing.
Outcome measures
| Measure |
Placebo Cohort A-D
n=9 Participants
Placebo daily for 28 days
|
10 mg LY3050258
n=7 Participants
10 mg LY3050258, daily for 28 days
|
30 mg LY3050258
n=9 Participants
30 mg LY3050258, daily for 28 days
|
90 mg LY3050258
n=9 Participants
90 mg LY3050258, daily for 28 days
|
180 mg LY3050258
n=9 Participants
180 mg LY3050258, daily for 28 days
|
360 mg LY3050258
360 mg LY3050258, daily for 28 days
|
Placebo Cohort E
Placebo daily for 28 days
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258
|
14.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 81
|
24.1 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
55.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
70.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
84.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 65
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrsPopulation: All participants who received at least one dose of study drug and had measurable Cmax PK concentrations after dosing.
Outcome measures
| Measure |
Placebo Cohort A-D
n=9 Participants
Placebo daily for 28 days
|
10 mg LY3050258
n=8 Participants
10 mg LY3050258, daily for 28 days
|
30 mg LY3050258
n=9 Participants
30 mg LY3050258, daily for 28 days
|
90 mg LY3050258
n=9 Participants
90 mg LY3050258, daily for 28 days
|
180 mg LY3050258
n=9 Participants
180 mg LY3050258, daily for 28 days
|
360 mg LY3050258
360 mg LY3050258, daily for 28 days
|
Placebo Cohort E
Placebo daily for 28 days
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258
|
0.899 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 93
|
1.35 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
3.58 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 61
|
4.51 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
4.99 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62
|
—
|
—
|
Adverse Events
Cohort A-D Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort A: 10 mg LY3050258
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B: 30 mg LY3050258
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort C: 90 mg LY3050258
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort D: 180 mg LY3050258
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort E: 360 mg LY3050258
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort E: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A-D Placebo
n=12 participants at risk
Placebo daily for 28 days
|
Cohort A: 10 mg LY3050258
n=11 participants at risk
10 mg LY3050258, daily for 28 days
|
Cohort B: 30 mg LY3050258
n=9 participants at risk
30 mg LY3050258, daily for 28 days
|
Cohort C: 90 mg LY3050258
n=10 participants at risk
90 mg LY3050258, daily for 28 days
|
Cohort D: 180 mg LY3050258
n=9 participants at risk
180 mg LY3050258, daily for 28 days
|
Cohort E: 360 mg LY3050258
n=9 participants at risk
360 mg LY3050258, daily for 28 days
|
Cohort E: Placebo
n=3 participants at risk
Placebo daily for 28 days
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
|
Vascular disorders
Haematoma
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
|
General disorders
Application site erythema
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Application site irritation
|
0.00%
0/12
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Application site pain
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
33.3%
3/9 • Number of events 3
|
0.00%
0/9
|
0.00%
0/3
|
|
General disorders
Application site rash
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Application site reaction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Application site warmth
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
|
General disorders
Vessel puncture site reaction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/9
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/3
|
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: OTHER