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
Not provided
Not provided
Not provided
An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.
This will be an open study conducted in healthy male subjects at a single centre. Each subject will participate in a screening visit and 2 study periods. At the first study period, all subjects will receive a single dose of BCT197 and at study period 2, all subjects will receive 3 daily doses of azithromycin and a single dose of BCT197.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 and Period 2 | Other | Period 1 - BCT197 14mg on Day 1 Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCT197 | Drug | A single dose of BCT197 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of Azithromycin. | Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72,96, 144, 168 hours post BCT197 dose on Day 1. Period 2: Pre BCT197 dose, 1, 2, 4, 6, 12, 24, 36, 48,72, 96,144, 168 and 336 hours post BCT197 dose on Day 1. | Pre-dose to Day 15 |
| Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of Azithromycin. | Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72,96, 144, 168 hours post BCT197 dose on Day 1. Period 2: Pre BCT197 dose, 1, 2, 4, 6, 12, 24, 36, 48,72, 96,144, 168 and 336 hours post BCT197 dose on Day 1. | Pre-dose to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin. | Day 1 to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected QT interval of the electrocardiogram (QTc). | Period 1: Pre-dose, 1, 2, 4, 6, 8, 24 and 168 hours post BCT197 dose on Day 1. Period 2: -22 hours, -16 hours, pre-dose azithromycin, 2, 4, 6, 8, 24, 168 and 336 hours post-dose (BCT197 on Day 1). | Pre-dose to Day 15 |
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Parkin, PhD FRCP | Mereo BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioKinetic Europe Ltd | Belfast | BT2 7BA | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000710710 | acumapimod |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Azithromycin | Drug | 3 daily doses of Azithromycin |
|
| Organic Chemicals |