NCT03046589

DP13 SAD & MAD in Healthy Male Subjects

Completed Phase 1 Last updated 17 April 2018

What this trial tests

Phase 1 trial testing DP13 in Safety and Tolerability in 48 participants. Completed in 27 March 2018.

Timeline

6 March 2017

Primary endpoint
14 March 2018

27 March 2018

Quick facts

Lead sponsor	Damian Pharma AG
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	48
Start date	6 March 2017
Primary completion	14 March 2018
Estimated completion	27 March 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• DP13 — full drug profile →
• placebo

Conditions studied

• Safety and Tolerability — all drugs for Safety and Tolerability →

Sponsor

Damian Pharma AG — full company profile →

Who can join

Adults 18 to 45, male only, with Safety and Tolerability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Aldosterone Synthase Inhibitors for Resistant Hypertension: Pharmacological Insights - A Systematic Review.
   Cicero AFG, Tocci G, Avagimyan A, Penson P, et al · · 2025 · cited 7× · PMID 40885884 · DOI 10.1007/s40265-025-02229-2