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| ID | Type | Description | Link |
|---|---|---|---|
| I6R-MC-DLAB | Other Identifier | Eli Lilly and Company |
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This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This study will evaluate the safety and how well the body tolerates LY3050258. It will last approximately 14 weeks with a 2 week follow-up appointment after the last treatment with study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3050258 | Experimental | Daily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg. |
|
| Placebo | Placebo Comparator | Daily dose of placebo matching LY3050258 for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3050258 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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. | Baseline to Study Completion (Up to 14 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | 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 hrs | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cypress | California | 90630 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A-D Placebo | Placebo daily for 28 days |
| FG001 | Cohort A: 10 Milligram (mg) LY3050258 | 10 mg LY3050258, daily for 28 days |
| FG002 | Cohort B: 30 mg LY3050258 | 30mg LY3050258, daily for 28 days |
| FG003 | Cohort C: 90 mg LY3050258 | 90 mg LY3050258, daily for 28 days |
| FG004 | Cohort D: 180 mg LY3050258 | 180 mg LY3050258, daily for 28 days |
| FG005 | Cohort E: 360 mg LY3050258 | 360 mg LY3050258, daily for 28 days |
| FG006 | Cohort E Placebo | Placebo daily for 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A-D Placebo | Placebo daily for 28 days |
| BG001 | Cohort A: LY3050258 | 10 mg LY3050258, daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to Study Completion (Up to 14 Weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A-D Placebo | Placebo daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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|
| 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 hrs |
| United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 |
| Cohort B: LY3050258 |
30 mg LY3050258, daily for 28 days |
| BG003 | Cohort C: LY3050258 | 90 mg LY3050258, daily for 28 days |
| BG004 | Cohort D: LY3050258 | 180 mg LY3050258, daily for 28 days |
| BG005 | Cohort E: LY3050258 | 360 mg LY3050258, daily for 28 days |
| BG006 | Cohort E Placebo | Placebo daily for 28 days |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
10 mg LY3050258, daily for 28 days
| OG002 | 30 mg LY3050258 | 30 mg LY3050258, daily for 28 days |
| OG003 | 90 mg LY3050258 | 90 mg LY3050258, daily for 28 days |
| OG004 | 180 mg LY3050258 | 180 mg LY3050258, daily for 28 days |
| OG005 | 360 mg LY3050258 | 360 mg LY3050258, daily for 28 days |
| OG006 | Placebo Cohort E | Placebo daily for 28 days |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 | All participants who received at least one dose of study drug and had measurable AUC PK concentrations after dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 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 hrs |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 | All participants who received at least one dose of study drug and had measurable Cmax PK concentrations after dosing. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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 hrs |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Cohort A: 10 mg LY3050258 | 10 mg LY3050258, daily for 28 days | 0 | 11 | 4 | 11 |
| EG002 | Cohort B: 30 mg LY3050258 | 30 mg LY3050258, daily for 28 days | 0 | 9 | 2 | 9 |
| EG003 | Cohort C: 90 mg LY3050258 | 90 mg LY3050258, daily for 28 days | 0 | 10 | 3 | 10 |
| EG004 | Cohort D: 180 mg LY3050258 | 180 mg LY3050258, daily for 28 days | 0 | 9 | 6 | 9 |
| EG005 | Cohort E: 360 mg LY3050258 | 360 mg LY3050258, daily for 28 days | 0 | 9 | 4 | 9 |
| EG006 | Cohort E: Placebo | Placebo daily for 28 days | 0 | 3 | 2 | 3 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site rash | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Application site warmth | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Electrocardiogram t wave abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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