NCT03046589

DP13 SAD & MAD in Healthy Male Subjects

A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Oral Dose, Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Study of DP13 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Damian Pharma AG · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	DP13	dose escalation
DRUG	placebo	control to dose-escalation

Timeline

• Start date: 2017-03-06
• Primary completion: 2018-03-14
• Completion: 2018-03-27
• First posted: 2017-02-08
• Last updated: 2018-04-17

Locations

1 site across 1 country: United Kingdom