DP13 SAD & MAD in Healthy Male Subjects

Summary

Primary Objectives: 1. To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects 2. To assess the pharmacodynamics of single and multiple ascending oral doses as well as dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects Secondary Objectives: 1. To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male subjects 2. To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male subjects

Timeline

Start

2017-03-06

Primary completion

2018-03-14

Completion

2018-03-27

Publications

• 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.

Drugs

Indications

No indication recorded.