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| ID | Type | Description | Link |
|---|---|---|---|
| I6R-MC-DLAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3050258 | Experimental | Single escalating dose of LY3050258 (2 milligram [mg] up to 200 mg) administered in up to two of two periods. |
|
| Placebo | Placebo Comparator | Single dose of placebo matching LY3050258 administered in up to one of two periods. |
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| 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 | Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module. | Baseline up to 21 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose. | |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] 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. | New York | New York | 10013 |
This was a single-dose, incomplete-crossover, dose-escalation study with minimum 7 days between dosing periods. Each participant received either 2 topical doses of LY3050258 or 1 topical dose each of LY3050258 and placebo. Two discontinued participants completing Period 1 were replaced in Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 2 milligrams (mg) LY3050258. |
| FG001 | 6 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 6 mg LY3050258. |
| FG002 | 20 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 20 mg LY3050258 |
| FG003 | Placebo (Trunk) | Period 1 or 2: Healthy participants received a topical application of placebo. |
| FG004 | 60 mg LY3050258 (Trunk) | Period 2: Healthy participants received a topical application of 60 mg LY3050258. |
| FG005 | 200 mg LY3050258 (Trunk) | Period 2: Healthy participants received a topical application of 200 mg LY3050258. |
| FG006 | 20 mg LY3050258 (Axilla) | Period 2: Healthy participants received a topical application of 20 mg LY3050258. |
| FG007 | Placebo (Axilla) | Period 2: Healthy participants received a topical application of placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 |
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| Washout Period ≥7 Days |
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| Intervention Period 2 |
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Participants who received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3050258 or Placebo | Participants received doses of 2, 6, or 20 mg LY3050258 or placebo during Period 1 by topical administration on the trunk. Participants received 60, 200 mg LY3050258 or placebo on the trunk or 20 mg LY3050258 or placebo by topical administration on the axilla during Period 2. There were at least 7 days between treatments. |
| Units | Counts |
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| Participants |
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| 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 | Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to 21 days postdose |
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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 | 2 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 2 mg LY3050258. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose |
| United States |
| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 6 mg LY3050258 (Trunk) |
Period 1: Healthy participants received a topical application of 6 mg LY3050258. |
| OG002 | 20 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 20 mg LY3050258. |
| OG003 | Placebo (Trunk) | Period 1 or 2: Healthy participants received a topical application of placebo. |
| OG004 | 60 mg LY3050258 (Trunk) | Period 2: Healthy participants received a topical application of 60 mg LY3050258. |
| OG005 | 200 mg LY3050258 (Trunk) | Period 2: Healthy participants received a topical application of 200 mg LY3050258. |
| OG006 | 20 mg LY3050258 (Axilla) | Period 2: Healthy participants received a topical application of 20 mg LY3050258. |
| OG007 | Placebo (Axilla) | Period 2: Healthy participants received a topical application of placebo. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258 | All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose. |
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| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 | All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose |
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|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 6 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 6 mg LY3050258. | 0 | 8 | 0 | 8 |
| EG002 | 20 mg LY3050258 (Trunk) | Period 1: Healthy participants received a topical application of 20 mg LY3050258. | 0 | 12 | 1 | 12 |
| EG003 | 20 mg LY3050258 (Axilla) | Period 2: Healthy participants received a topical application of 20 mg LY3050258. | 0 | 12 | 1 | 12 |
| EG004 | 60 mg LY3050258 (Trunk) | Period 2: Healthy participants received a topical application of 60 mg LY3050258. | 0 | 6 | 0 | 6 |
| EG005 | 200 mg LY3050258 (Trunk) | Period 2: Healthy participants received a topical application of 200 mg LY3050258. | 0 | 8 | 1 | 8 |
| EG006 | Placebo (Trunk) | Period 1 or 2: Healthy participants received a topical application of placebo. | 0 | 15 | 1 | 15 |
| EG007 | Placebo (Axilla) | Period 2: Healthy participants received a topical application of placebo. | 0 | 4 | 1 | 4 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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