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
| Name | Class |
|---|---|
| Covance | INDUSTRY |
| Foundation for Therapeutic Research, Lausanne | UNKNOWN |
| Insel Gruppe AG, University Hospital Bern | OTHER |
Not provided
Not provided
Not provided
Primary Objectives:
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Period 1 | Experimental | DP13 capsules (dose level 1 ) and placebo capsules |
|
| Treatment Period 2 | Experimental | DP13 capsules (dose level 2) and placebo capsules |
|
| Treatment Period 3 | Experimental | DP13 capsules (dose level 3) and placebo capsules |
|
| Treatment Period 4 | Experimental | DP13 capsules (dose level 4) and placebo capsules |
|
| Treatment Period 5 | Experimental | DP13 capsules (dose level 5) and placebo capsules |
|
| Treatment Period 6 | Experimental | DP13 capsules (dose level 6) and placebo capsules |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DP13 | Drug | dose escalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (Clinical signs and symptoms incl ECG, vital signs, electrolytes) | Clinical signs and symptoms incl ECG, vital signs, electrolytes | Up to 2 weeks after dosing |
| Aldosterone suppression | Serum aldosterone concentration | Up to 48 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Plasma DP13 concentration) | Plasma DP13 concentration | up to 48 hours after dosing |
| Pharmacodynamic selectivity (Plasma hormone concentrations) | Plasma hormone concentrations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ashley Brooks, MBChB | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd | Leeds | LS2 9LH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36914591 | Derived | Mulatero P, Groessl M, Vogt B, Schumacher C, Steele RE, Brooks A, Hossack S, Brunner HR. CYP11B2 inhibitor dexfadrostat phosphate suppresses the aldosterone-to-renin ratio, an indicator of sodium retention, in healthy volunteers. Br J Clin Pharmacol. 2023 Aug;89(8):2483-2496. doi: 10.1111/bcp.15713. Epub 2023 Apr 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo | Drug | control to dose-escalation |
|
| Up to 48 hours after dosing |