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DP13 SAD & MAD in Healthy Male Subjects

NCT03046589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-04-17

No results posted yet for this study

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

DRUG

DP13

dose escalation

DRUG

placebo

control to dose-escalation

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Foundation for Therapeutic Research, Lausanne

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • Damian Pharma AG

    lead INDUSTRY

Principal Investigators

  • Ashley Brooks, MBChB · Covance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2018-03-14
Completion
2018-03-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03046589 on ClinicalTrials.gov