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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04091373 | A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide | PHASE1 | COMPLETED | 36 | — | — | Sep 27, 2019 | Mar 6, 2020 | Apr 7, 2020 | 1 | United States |
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | 100ug SC injection cotadutide in the upper arm on Day 1, in the lower abdomen on Day 8, and in the thigh on Day 15 |
| Sequence 2 | EXPERIMENTAL | 100ug SC injection cotadutide in the thigh on Day 1, in the upper arm on Day 8, and in the lower abdomen on Day 15 |
| Sequence 3 | EXPERIMENTAL | 100ug SC injection cotadutide in the lower abdomen on Day 1, in the thigh on Day 8, and in the upper arm on Day 15 |
| Sequence 4 | EXPERIMENTAL | 100ug SC injection cotadutide in the thigh on Day 1, in the lower abdomen on Day 8, and in the upper arm on Day 15 |
| Sequence 5 | EXPERIMENTAL | 100ug SC injection cotadutide in the lower abdomen on Day 1, in the upper arm on Day 8, and in the thigh on Day 15 |
| Sequence 6 | EXPERIMENTAL | 100ug SC injection cotadutide in the upper arm on Day 1, in the thigh on Day 8, and in the lower abdomen on Day 15 |
| Name | Type | Description |
|---|---|---|
| cotadutide multidose pen injection | COMBINATION_PRODUCT | SC injection in the upper arm |
Inclusion Criteria: 1. Healthy subjects aged 18 through 60 years (inclusive) at the time of screening. 2. Electronic and/or written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 3. BMI between 19 and 30 kg/m2 (inclus...