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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-JE-ITRK | Other Identifier | Eli Lilly and Company |
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The aims of this study are to evaluate:
The study has two parts. Participants may only enroll in one part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treprostinil (Part A) | Experimental | Treprostinil administered as a single subcutaneous (SC) bolus injection. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered as a single SC bolus injection. |
|
| LY900014 (Part B) | Experimental | LY900014 (test) administered as a single SC bolus injection. |
|
| Insulin Lispro (Part B) | Active Comparator | Insulin lispro (reference) administered as a single SC bolus injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil | Drug | Administered SC. |
| |
| 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module. | Part A: Baseline through Study Completion (up to 14 Days after Last Dose) |
| Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B) | PK: Insulin Lispro Cmax (Part B) | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose |
| PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B) | PK: Insulin Lispro AUC(0-30min) (Part B) | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A) | PK: Treprostinil Tmax (Part A) | 15, 30, 60 and 120 Minutes Postdose |
| PK: Maximum Concentration (Cmax) of Treprostinil (Part A) | PK: Cmax of Treprostinil (Part A) |
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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. | Fukuoka | 812-0025 |
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This study had two parts: Part A was a two-period crossover. Part B was a three-period crossover with dose escalation. Healthy Japanese participants were eligible to enroll in one part. One randomized participant discontinued prior to study completion and was replaced. The replacement adopted the original participant's randomization scheme.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Treprostinil (Part A) | Placebo given subcutaneously (SC) once in first study period. 1,000 nanograms (ng) of treprostinil given SC once in second study period. There was a minimum three day washout between doses. |
| FG001 | Treprostinil/Placebo (Part A) | 1,000 ng of treprostinil given SC once in first study period. Matching placebo given SC once in second study period. There was a minimum three day washout between doses. |
| FG002 | 15 U Insulin Lispro/15 U LY900014/30 U LY900014 (Part B) | 15 units (U) insulin lispro given SC once in first study period. 15 U LY900014 given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses. |
| FG003 | 7.5 U LY900014/15 U Insulin Lispro/30 U LY900014 (Part B) | 7.5 U LY900014 given SC once in first study period. 15 U insulin lispro given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses. |
| FG004 | 7.5 U LY900014/15 U LY900014/15 U Insulin Lispro (Part B) | 7.5 U LY900014 given SC once in first study period. 15 U LY900014 given SC once in second study period. 15 U insulin lispro given SC once in third study period. There was a minimum three day washout between doses. |
| FG005 | 7.5 U LY900014/15 U LY900014/30 U LY900014 (Part B) | 7.5 U LY900014 given SC once in first study period. 15 U LY900014 given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One |
| ||||||||||||||||
| Period Two |
| ||||||||||||||||
| Period Three |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treprostinil or Placebo (Part A) | Participants received either 1000 ng of treprostinil or matching placebo as a SC injection once in each of two study periods. |
| BG001 | LY900014 or Insulin Lispro (Part B) |
| 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module. | All participants who received at least one dose of study drug. | Posted | Number | participants | Part A: Baseline through Study Completion (up to 14 Days after Last Dose) |
|
Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
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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 | Placebo (Part A) | Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site phlebitis | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Administered SC. |
|
| LY900014 | Drug | Administered SC. |
|
|
| Insulin Lispro | Drug | Administered SC. |
|
| 15, 30, 60 and 120 Minutes Postdose |
| Japan |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
Participants received each of three doses of LY900014 (7.5 U, 15 U, 30 U) or 15 U of insulin lispro as a SC injection once in each of three study periods.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared (kg/m²) |
|
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
| OG002 | 15 U Insulin Lispro (Part B) | 15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses. |
| OG003 | 7.5 U LY900014 (Part B) | 7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses. |
| OG004 | 15 U LY900014 (Part B) | 15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses. |
| OG005 | 30 U LY900014 (Part B) | 30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses. |
|
|
| Primary | Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B) | PK: Insulin Lispro Cmax (Part B) | All participants who received at least one dose of study drug LY900014 in Part B and had evaluable pharmacokinetic data. Per protocol, PK in Part B was not analyzed for 15 U Insulin Lispro (Humalog). This arm was included for only safety analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles/liter (pmol/L) | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose |
|
|
|
| Primary | PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B) | PK: Insulin Lispro AUC(0-30min) (Part B) | All participants who received at least one dose of study drug LY900014 in Part B and had evaluable pharmacokinetic data. Per protocol, PK in Part B was not analyzed for 15 U Insulin Lispro (Humalog). This arm was included for only safety analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol*hour/L (pmol*hr/L) | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose |
|
|
|
| Secondary | PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A) | PK: Treprostinil Tmax (Part A) | All participants in Part A who received study drug and had evaluable pharmacokinetic data. | Posted | Median | Full Range | hours | 15, 30, 60 and 120 Minutes Postdose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of Treprostinil (Part A) | PK: Cmax of Treprostinil (Part A) | All participants in Part A who received study drug and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/milliliter (mL) | 15, 30, 60 and 120 Minutes Postdose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Treprostinil (Part A) | 1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | 15 U Insulin Lispro (Part B) | 15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | 7.5 U LY900014 (Part B) | 7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses. | 0 | 13 | 0 | 13 | 7 | 13 |
| EG004 | 15 U LY900014 (Part B) | 15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses. | 0 | 13 | 0 | 13 | 7 | 13 |
| EG005 | 30 U LY900014 (Part B) | 30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses. | 0 | 13 | 0 | 13 | 2 | 13 |
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |