A Study of LY3079514 in Healthy Participants
Study Details
Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY3079514 Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion |
Drug: LY3079514
Administered SC
Drug: LY3079514
Administered IV
|
Placebo Comparator: Placebo Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. |
Drug: Placebo
Administered SC
Drug: Placebo
Administered IV
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline to Study Completion (Up to 12 Weeks)]
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.
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 [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,D85]
- PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 [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,D85]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Overtly healthy participants as determined by medical history and physical examination
-
To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese
-
Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m^2) and have a minimum body weight of 50 kilograms (kg), inclusive at screening
-
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Exclusion Criteria:
-
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
-
Have an abnormal blood pressure that is considered to be clinically significant, as determined by the investigator
-
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
-
Have known or ongoing psychiatric disorders
-
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
-
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
-
Show evidence of hepatitis C and/or positive hepatitis C antibody
-
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | California Clinical Trials Medical Group | Glendale | California | United States | 91206 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15190
- I7B-MC-DPAA
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Placebo | LY3079514 Cohort 1 | LY3079514 Cohort 2 | LY3079514 Cohort 3 | LY3079514 Cohort 4 | LY3079514 Cohort 5 | LY3079514 Cohort 6 |
---|---|---|---|---|---|---|---|
Arm/Group Description | Single dose of placebo matching LY3079514 administered intravenous (IV) infusion or subcutaneous (SC) injection during a single occasion. | 7 milligrams (mg) single dose of LY3079514 administered by SC injection during a single occasion. | 21 mg single dose of LY3079514 administered by SC injection during a single occasion. | 70 mg single dose of LY3079514 administered by SC injection during a single occasion. | 210 mg single dose of LY3079514 administered by SC injection during a single occasion. | 70 mg single dose of LY3079514 administered IV during a single occasion. | 210 mg single dose of LY3079514 administered IV during a single occasion. |
Period Title: Overall Study | |||||||
STARTED | 12 | 6 | 6 | 6 | 6 | 6 | 6 |
Received at Least One Dose of Study Drug | 12 | 6 | 6 | 6 | 6 | 6 | 6 |
COMPLETED | 11 | 6 | 6 | 6 | 6 | 6 | 6 |
NOT COMPLETED | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 | Total |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. | 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered by SC during a single occasion | 210 mg single dose of LY3079514 administered by SC during a single occasion | 70 mg single dose of LY3079514 administered IV during a single occasion | 210 mg single dose of LY3079514 administered IV during a single occasion | Total of all reporting groups |
Overall Participants | 12 | 6 | 6 | 6 | 6 | 6 | 6 | 48 |
Age (years) [Mean (Standard Deviation) ] | ||||||||
Mean (Standard Deviation) [years] |
41.1
(11.96)
|
35.5
(10.82)
|
34.5
(12.42)
|
38.0
(12.82)
|
45.3
(12.39)
|
39.0
(11.56)
|
49.3
(5.61)
|
40.5
(11.65)
|
Sex: Female, Male (Count of Participants) | ||||||||
Female |
4
33.3%
|
1
16.7%
|
1
16.7%
|
0
0%
|
3
50%
|
0
0%
|
3
50%
|
12
25%
|
Male |
8
66.7%
|
5
83.3%
|
5
83.3%
|
6
100%
|
3
50%
|
6
100%
|
3
50%
|
36
75%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
Hispanic or Latino |
1
8.3%
|
0
0%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
6
12.5%
|
Not Hispanic or Latino |
11
91.7%
|
6
100%
|
5
83.3%
|
5
83.3%
|
5
83.3%
|
5
83.3%
|
5
83.3%
|
42
87.5%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (participants) [Number] | ||||||||
Japanese |
3
25%
|
0
0%
|
3
50%
|
0
0%
|
3
50%
|
0
0%
|
3
50%
|
12
25%
|
Non-Japanese |
9
75%
|
6
100%
|
3
50%
|
6
100%
|
3
50%
|
6
100%
|
3
50%
|
36
75%
|
Region of Enrollment (participants) [Number] | ||||||||
United States |
12
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
48
100%
|
Outcome Measures
Title | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
---|---|
Description | 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. |
Time Frame | Baseline to Study Completion (Up to 12 Weeks) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug. |
Arm/Group Title | Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 |
---|---|---|---|---|---|---|---|
Arm/Group Description | Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion | 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered by SC during a single occasion | 210 mg single dose of LY3079514 administered by SC during a single occasion | 70 mg single dose of LY3079514 administered IV during a single occasion | 210 mg single dose of LY3079514 administered IV during a single occasion |
Measure Participants | 12 | 6 | 6 | 6 | 6 | 6 | 6 |
Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 |
---|---|
Description | |
Time Frame | 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,D85 |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants who received at least 1 dose of study drug and had evaluable Cmax PK data. |
Arm/Group Title | LY Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 |
---|---|---|---|---|---|---|
Arm/Group Description | 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered by SC injection during a single occasion | 210 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered IV during a single occasion | 210 mg single dose of LY3079514 administered IV during a single occasion |
Measure Participants | 5 | 6 | 6 | 6 | 6 | 6 |
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter (ng/mL)] |
55.1
(93)
|
480
(64)
|
3150
(118)
|
16900
(45)
|
19000
(13)
|
41300
(22)
|
Title | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 |
---|---|
Description | |
Time Frame | 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,D85 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | LY Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 |
---|---|---|---|---|---|---|
Arm/Group Description | 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered by SC injection during a single occasion | 210 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered IV during a single occasion | 210 mg single dose of LY3079514 administered IV during a single occasion |
Measure Participants | 0 | 4 | 4 | 6 | 6 | 6 |
Geometric Mean (Geometric Coefficient of Variation) [nanogram•hour/milliliter (ng•h/mL)] |
38500
(59)
|
402000
(80)
|
4850000
(37)
|
1240000
(20)
|
6470000
(14)
|
Adverse Events
Time Frame | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||||||
Arm/Group Title | Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 | |||||||
Arm/Group Description | Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. | 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered by SC injection during a single occasion | 210 mg single dose of LY3079514 administered by SC injection during a single occasion | 70 mg single dose of LY3079514 administered IV during a single occasion | 210 mg single dose of LY3079514 administered IV during a single occasion | |||||||
All Cause Mortality |
||||||||||||||
Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/12 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 | LY Cohort 5 | LY Cohort 6 | ||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/12 (8.3%) | 4/6 (66.7%) | 1/6 (16.7%) | 3/6 (50%) | 4/6 (66.7%) | 3/6 (50%) | 4/6 (66.7%) | |||||||
Eye disorders | ||||||||||||||
Eye swelling | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Eyelid oedema | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Periorbital oedema | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
Gastrointestinal disorders | ||||||||||||||
Abdominal pain lower | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
General disorders | ||||||||||||||
Generalised oedema | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Instillation site bruise | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Oedema | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Oedema peripheral | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Infections and infestations | ||||||||||||||
Laryngitis | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Upper respiratory tract infection | 0/12 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Urinary tract infection | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||||||
Laceration | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||||||
Bone pain | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Costochondritis | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Tendon pain | 1/12 (8.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Nervous system disorders | ||||||||||||||
Dizziness | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Lethargy | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Reproductive system and breast disorders | ||||||||||||||
Postmenopausal haemorrhage | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Premenstrual headache | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||||||
Dyspnoea | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Haemoptysis | 0/12 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Nasal congestion | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Sinus congestion | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||||||
Pruritus generalised | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Rash erythematous | 0/12 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Skin irritation | 0/12 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
- 15190
- I7B-MC-DPAA