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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-FW-ITCA | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine:
Part A
Part B:
Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lispro (A) | Experimental | Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods. |
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| Part A: Lispro (B) | Experimental | Formulation B: Single dose of lispro administered SC in one of five periods. |
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| Part A: Lispro (C) | Experimental | Formulation C: Single dose of lispro administered SC in one of five periods. |
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| Part A: Lispro (D) | Experimental | Formulation D: Single dose of lispro administered SC in one of five periods. |
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| Part A: Lispro (Reference) | Experimental | Reference formulation: Single dose of lispro administered SC in one of five periods. |
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| Part B: Lispro | Experimental | Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lispro | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) | Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration. | -30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes |
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Inclusion Criteria:
- Overtly healthy males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination
Exclusion Criteria:
- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Singapore | Singapore |
Part A was a 5-period crossover study and Part B was a 4-period crossover study. A washout of 72 hours was observed between doses with a follow up within 7 to 14 days after the last dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Lispro Sequence 1 | Each participant received a single subcutaneous (SC) dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3. Sequence 1: Test A, D, C, Reference, B |
| FG001 | Part A: Lispro Sequence 2 | Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3. Sequence 2: Test B, A, Reference, C, D |
| FG002 | Part A: Lispro Sequence 3 | Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3. Sequence 3: Test Reference, Test C, B, D, A. |
| FG003 | Part B: Lispro Sequence 1 | Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection. Sequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U |
| FG004 | Part B Lispro Sequence 2 | Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection. Sequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U |
| FG005 | Part B Lispro Sequence 3 | Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection. Sequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A and Part B Period 1 |
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| Part A and B Period 2 |
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| Part A and B Period 3 |
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| Part A and Part B Period 4 |
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| Part A Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Participants | Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3. Sequence 1: Test A, D, C, Reference, B Sequence 2: Test B, A, Reference, C, D Sequence 3: Test Reference, Test C, B, D, A. |
| Units | Counts |
|---|---|
| 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 | Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) | Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration. | All randomized participants who were completers and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hour/Liter (pmol*hr/L) | -30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes |
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54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.
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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 | Part A: Lispro (7.0 U - Reference) | Reference formulation: Single dose of lispro administered SC in one of five periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eli Lilly and Company | Chief Medical Officer | 800-545-5979 |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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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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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Part B Participants | Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection. Sequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U Sequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U Sequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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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Formulation A: Single dose of lispro administered SC in one of five periods. |
| OG002 | Part A: Lispro (7.28 U - Test B) | Formulation B: Single dose of lispro administered SC in one of five periods. |
| OG003 | Part A: Lispro (7.28 U - Test C) | Formulation C: Single dose of lispro administered SC in one of five periods. |
| OG004 | Part A: Lispro (7.28 U - Test D) | Formulation D: Single dose of lispro administered SC in one of five periods. |
| OG005 | Part B: Lispro (7.28 U - Test B) | Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. |
| OG006 | Part B: Lispro (15.47 U - Test B) | Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. |
| OG007 | Part B: Lispro (30.03 U - Test B) | Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. |
|
|
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| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Part A: Lispro (7.28 U - Test A) | Formulation A: Single dose of lispro administered SC in one of five periods. | 0 | 24 | 4 | 24 |
| EG002 | Part A: Lispro (7.28 U - Test B) | Formulation B: Single dose of lispro administered SC in one of five periods. | 0 | 24 | 4 | 24 |
| EG003 | Part A: Lispro (7.28 U - Test C) | Formulation C: Single dose of lispro administered SC in one of five periods. | 0 | 24 | 4 | 24 |
| EG004 | Part A: Lispro (7.28 U - Test D) | Formulation D: Single dose of lispro administered SC in one of five periods. | 0 | 24 | 2 | 24 |
| EG005 | Part B: Lispro (7.28 U - Test B) | Formulation selected from Part B. Single dose of lispro administered SC in one of four periods. | 0 | 28 | 6 | 28 |
| EG006 | Part B: Lispro (15.47 U - Test B) | Formulation selected from Part B. Single dose of lispro administered SC in one of four periods. | 0 | 28 | 3 | 28 |
| EG007 | Part B: Lispro (30.03 U - Test B) | Formulation selected from Part B. Single dose of lispro administered SC in one of four periods. | 0 | 29 | 7 | 29 |
| Catheter site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |