Trial Outcomes & Findings for A Study of LY3079514 in Healthy Participants (NCT NCT02242903)
NCT ID: NCT02242903
Last Updated: 2018-10-04
Results Overview
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline to Study Completion (Up to 12 Weeks)
Results posted on
2018-10-04
Participant Flow
Participant milestones
| Measure |
Placebo
Single dose of placebo matching LY3079514 administered intravenous (IV) infusion or subcutaneous (SC) injection during a single occasion.
|
LY3079514 Cohort 1
7 milligrams (mg) single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 2
21 mg single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 3
70 mg single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 4
210 mg single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 5
70 mg single dose of LY3079514 administered IV during a single occasion.
|
LY3079514 Cohort 6
210 mg single dose of LY3079514 administered IV during a single occasion.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Single dose of placebo matching LY3079514 administered intravenous (IV) infusion or subcutaneous (SC) injection during a single occasion.
|
LY3079514 Cohort 1
7 milligrams (mg) single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 2
21 mg single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 3
70 mg single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 4
210 mg single dose of LY3079514 administered by SC injection during a single occasion.
|
LY3079514 Cohort 5
70 mg single dose of LY3079514 administered IV during a single occasion.
|
LY3079514 Cohort 6
210 mg single dose of LY3079514 administered IV during a single occasion.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3079514 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
|
LY3079514 (LY) Cohort 1
n=6 Participants
7 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 2
n=6 Participants
21 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 3
n=6 Participants
70 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 4
n=6 Participants
210 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 5
n=6 Participants
70 mg single dose of LY3079514 administered IV during a single occasion
|
LY Cohort 6
n=6 Participants
210 mg single dose of LY3079514 administered IV during a single occasion
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 12.82 • n=4 Participants
|
45.3 years
STANDARD_DEVIATION 12.39 • n=21 Participants
|
39.0 years
STANDARD_DEVIATION 11.56 • n=10 Participants
|
49.3 years
STANDARD_DEVIATION 5.61 • n=115 Participants
|
40.5 years
STANDARD_DEVIATION 11.65 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
36 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
42 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=10 Participants
|
3 participants
n=115 Participants
|
12 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non-Japanese
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
3 participants
n=115 Participants
|
36 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
48 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (Up to 12 Weeks)Population: All randomized participants who received at least 1 dose of study drug.
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=12 Participants
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion
|
LY3079514 (LY) Cohort 1
n=6 Participants
7 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 2
n=6 Participants
21 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 3
n=6 Participants
70 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 4
n=6 Participants
210 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 5
n=6 Participants
70 mg single dose of LY3079514 administered IV during a single occasion
|
LY Cohort 6
n=6 Participants
210 mg single dose of LY3079514 administered IV during a single occasion
|
|---|---|---|---|---|---|---|---|
|
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: SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85Population: All randomized participants who received at least 1 dose of study drug and had evaluable Cmax PK data.
Outcome measures
| Measure |
Placebo
n=5 Participants
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion
|
LY3079514 (LY) Cohort 1
n=6 Participants
7 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 2
n=6 Participants
21 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 3
n=6 Participants
70 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 4
n=6 Participants
210 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 5
n=6 Participants
70 mg single dose of LY3079514 administered IV during a single occasion
|
LY Cohort 6
210 mg single dose of LY3079514 administered IV during a single occasion
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
|
55.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 93
|
480 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 64
|
3150 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 118
|
16900 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
19000 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
41300 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85Population: All randomized participants who received at least 1 dose of investigational drug and had evaluable AUC PK data. Cohort 1 had zero participants analyzed and was not included in summary statistics.
Outcome measures
| Measure |
Placebo
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion
|
LY3079514 (LY) Cohort 1
n=4 Participants
7 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 2
n=4 Participants
21 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 3
n=6 Participants
70 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 4
n=6 Participants
210 mg single dose of LY3079514 administered by SC during a single occasion
|
LY Cohort 5
n=6 Participants
70 mg single dose of LY3079514 administered IV during a single occasion
|
LY Cohort 6
210 mg single dose of LY3079514 administered IV during a single occasion
|
|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
|
—
|
38500 nanogram•hour/milliliter (ng•h/mL)
Geometric Coefficient of Variation 59
|
402000 nanogram•hour/milliliter (ng•h/mL)
Geometric Coefficient of Variation 80
|
4850000 nanogram•hour/milliliter (ng•h/mL)
Geometric Coefficient of Variation 37
|
1240000 nanogram•hour/milliliter (ng•h/mL)
Geometric Coefficient of Variation 20
|
6470000 nanogram•hour/milliliter (ng•h/mL)
Geometric Coefficient of Variation 14
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY3079514 (LY) Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY Cohort 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY Cohort 6
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
|
LY3079514 (LY) Cohort 1
n=6 participants at risk
7 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 2
n=6 participants at risk
21 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 3
n=6 participants at risk
70 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 4
n=6 participants at risk
210 mg single dose of LY3079514 administered by SC injection during a single occasion
|
LY Cohort 5
n=6 participants at risk
70 mg single dose of LY3079514 administered IV during a single occasion
|
LY Cohort 6
n=6 participants at risk
210 mg single dose of LY3079514 administered IV during a single occasion
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye swelling
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/12
|
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
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12
|
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
|
|
General disorders
Generalised oedema
|
0.00%
0/12
|
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
|
|
General disorders
Instillation site bruise
|
0.00%
0/12
|
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
|
|
General disorders
Oedema
|
0.00%
0/12
|
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
|
|
General disorders
Oedema peripheral
|
0.00%
0/12
|
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
Laryngitis
|
0.00%
0/12
|
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
Upper respiratory tract infection
|
0.00%
0/12
|
33.3%
2/6 • Number of events 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
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12
|
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
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/12
|
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
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12
|
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
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/12
|
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
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
8.3%
1/12 • 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%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12
|
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
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Premenstrual headache
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12
|
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
Haemoptysis
|
0.00%
0/12
|
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
Nasal congestion
|
0.00%
0/12
|
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
Sinus congestion
|
0.00%
0/12
|
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
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/12
|
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
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/12
|
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
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12
|
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