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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04002427 | Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594 | PHASE1 | COMPLETED | 6 | — | — | Jun 11, 2019 | Jul 5, 2019 | Jul 25, 2019 | 1 | United Kingdom |
Assessment of total radioactivity by measuring AZD7594 excreted (Ae)
Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (Fe)
Assessment of total radioactivity by measuring the cumulative amount of AZD7594 excreted (CumAe)
Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
| Arm | Type | Description |
|---|---|---|
| Only one study arm | EXPERIMENTAL | \[14C\]AZD7594 Solution for Infusion 5 µg/mL (1.1 kBq/mL) AZD7594 Inhalation Powder, SD3FL Inhaler |
| Name | Type | Description |
|---|---|---|
| Intravenous Infusion | DRUG | 30 µg \[14C\]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 hour infusion. |
| Inhaled dose | DRUG | A single inhalation on one occasion. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male or non-pregnant, non-lactating female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture. 3. Have a body mass index of 18.5 t...