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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02950805 | A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis | PHASE1 | COMPLETED | 9 | — | — | May 30, 2017 | Apr 12, 2018 | Jul 13, 2018 | 3 | United States |
Assessment of the average whole lung clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634, (%MCC 0--60, whole) in subjects with cystic fibrosis (CF).
| Arm | Type | Description |
|---|---|---|
| Placebo + AZD5634 | EXPERIMENTAL | Subjects were administered single dose of placebo in period 1 and AZD5634 in period 2. |
| AZD5634 + Placebo | EXPERIMENTAL | Subjects were administered single dose of AZD5634 in period 1 and placebo in period 2. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Subjects will receive a placebo in either period 1 or period 2 by inhalation. |
| AZD5634 | DRUG | Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation. |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Male or female patients aged 18-60 years old inclusive. 3. Diagnosed of CF at Screening as evidenced in medical records by one of the following criteria: 1. sweat chloride ≥ ...