DP13 SAD & MAD in Healthy Male Subjects

Sponsor

Damian Pharma AG (Industry)

Overall Status

Completed

CT.gov ID

NCT03046589

Collaborator

Covance (Industry), Foundation for Therapeutic Research, Lausanne (Other), University Hospital Inselspital, Berne (Other)

Enrollment

Location

Arms

12.7

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objectives:

To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects
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:

To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male subjects
To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male subjects

Condition or Disease	Intervention/Treatment	Phase
Safety and Tolerability	Drug: DP13 Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 6, 2017

Actual Primary Completion Date :

Mar 14, 2018

Actual Study Completion Date :

Mar 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Period 1 DP13 capsules (dose level 1 ) and placebo capsules	Drug: DP13 dose escalation Drug: placebo control to dose-escalation
Experimental: Treatment Period 2 DP13 capsules (dose level 2) and placebo capsules	Drug: DP13 dose escalation Drug: placebo control to dose-escalation
Experimental: Treatment Period 3 DP13 capsules (dose level 3) and placebo capsules	Drug: DP13 dose escalation Drug: placebo control to dose-escalation
Experimental: Treatment Period 4 DP13 capsules (dose level 4) and placebo capsules	Drug: DP13 dose escalation Drug: placebo control to dose-escalation
Experimental: Treatment Period 5 DP13 capsules (dose level 5) and placebo capsules	Drug: DP13 dose escalation Drug: placebo control to dose-escalation
Experimental: Treatment Period 6 DP13 capsules (dose level 6) and placebo capsules	Drug: DP13 dose escalation Drug: placebo control to dose-escalation

Outcome Measures

Primary Outcome Measures

Safety and Tolerability (Clinical signs and symptoms incl ECG, vital signs, electrolytes) [Up to 2 weeks after dosing]
Clinical signs and symptoms incl ECG, vital signs, electrolytes
Aldosterone suppression [Up to 48 hours after dosing]
Serum aldosterone concentration

Secondary Outcome Measures

Pharmacokinetics (Plasma DP13 concentration) [up to 48 hours after dosing]
Plasma DP13 concentration
Pharmacodynamic selectivity (Plasma hormone concentrations) [Up to 48 hours after dosing]
Plasma hormone concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI between 18.0 and 30.0 kg/m2, inclusive
body weight between 60 and 95 kg, inclusive
good health as determined by medical history, physical examination, vital signs assessment, 12-lead ECG, clinical laboratory evaluations
normal stress response
sodium value within the normal laboratory reference range
potassium value within the normal laboratory reference range
written informed consent

Exclusion Criteria:

unwilling to consent or whose partner is unwilling to consent to use a barrier method of contraception
blood donation within 3 months prior to screening or plasma donation within 7 days prior to screening or platelet donation within 6 weeks prior to screening
consumption of more than 28 units of alcohol per week or significant history of alcoholism or drug/chemical abuse within the last 12 months prior to screening
use of tobacco or nicotine-containing products within 3 months
use of any of the following within 14 days of first dose: non-prescribed systemic or topical medication; any herbal remedy; any vitamin supplement; any mineral supplement
receipt of any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes
receipt or intent to receive: any prescribed systemic or topical medication within 14 days of first dose administration
an abnormality in heart rate, blood pressure, temperature or respiration rate at screening and prior to first dose that in the opinion of the investigator increases the risk of participating in the study
a positive urine drugs of abuse screen
an abnormality in the 12-lead ECG at screening and prior to first dose that in the opinion of the investigator increases the risk of participating in the study
a medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
participation in another clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Ltd	Leeds		United Kingdom	LS2 9LH

Sponsors and Collaborators

Damian Pharma AG
Covance
Foundation for Therapeutic Research, Lausanne
University Hospital Inselspital, Berne

Investigators

Principal Investigator: Ashley Brooks, MBChB, Covance

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Damian Pharma AG

ClinicalTrials.gov Identifier:

NCT03046589

Other Study ID Numbers:

DP13C101

First Posted:

Feb 8, 2017

Last Update Posted:

Apr 17, 2018

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Apr 17, 2018