Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02293551 | A Study of Lispro Formulations in Healthy Participants | PHASE1 | COMPLETED | 54 | — | — | Dec 1, 2014 | Sep 1, 2015 | Sep 8, 2025 | 1 | Singapore |
Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.
| Arm | Type | Description |
|---|---|---|
| Part A: Lispro (A) | EXPERIMENTAL | Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods. |
| Part A: Lispro (B) | EXPERIMENTAL | Formulation B: Single dose of lispro administered SC in one of five periods. |
| Part A: Lispro (C) | EXPERIMENTAL | Formulation C: Single dose of lispro administered SC in one of five periods. |
| Part A: Lispro (D) | EXPERIMENTAL | Formulation D: Single dose of lispro administered SC in one of five periods. |
| Part A: Lispro (Reference) | EXPERIMENTAL | Reference formulation: Single dose of lispro administered SC in one of five periods. |
| Part B: Lispro | EXPERIMENTAL | Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. |
| Name | Type | Description |
|---|---|---|
| Lispro | DRUG | Administered SC |
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)...