Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BUS-P1-09 | Other Identifier | Bellus Health Inc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Release formulation | Active Comparator | IR Formulation |
|
| Extended Release formulation | Experimental | ER formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-5937 IR | Drug | Each subject will receive two single and multiple administrations of Immediate Release reference formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the maximum observed plasma drug concentration (Cmax) | To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation. | Pre dose up to 36 hours post-dose |
| Measurement of the minimum observed plasma drug concentration (Cmin) | To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation. | Pre dose up to 36 hours post-dose |
| Measurement of the area under the plasma drug concentration by time curve AUC | To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation. | Pre dose up to 36 hours post-dose |
| Measurement of the observed plasma drug concentration 24 hours post-dose (C24) | To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation. | 24 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nottingham | NG11 6JS | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BLU-5937 ER | Drug | Each subject will receive single and multiple oral administrations of Extended Release formulation |
|
| D013568 | Pathological Conditions, Signs and Symptoms |