A Study of LY3079514 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02242903
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 6

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
Healthy Volunteers	Drug: LY3079514; Drug: LY3079514; Drug: Placebo; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3079514 in Healthy Subjects
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

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

1. 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

1. 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]

2. 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

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02242903
• Other Study ID Numbers: 15190; I7B-MC-DPAA
• First Posted: Sep 17, 2014
• Last Update Posted: Oct 4, 2018
• Last Verified: Feb 1, 2018

Study Results

Participant Flow

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

1. Primary Outcome

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%

2. Secondary Outcome

Title	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
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)

3. Secondary Outcome

Title	PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
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

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

[Not Specified]

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.