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

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

Study Overview

• Status: Completed
• Conditions: Safety and Tolerability
• Intervention / Treatment: Drug: DP13; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical Research Unit Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. unwilling to consent or whose partner is unwilling to consent to use a barrier method of contraception
2. 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
3. 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
4. use of tobacco or nicotine-containing products within 3 months
5. 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
6. receipt of any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes
7. receipt or intent to receive: any prescribed systemic or topical medication within 14 days of first dose administration
8. 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
9. a positive urine drugs of abuse screen
10. 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
11. a medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
12. participation in another clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability (Clinical signs and symptoms incl ECG, vital signs, electrolytes)	Clinical signs and symptoms incl ECG, vital signs, electrolytes	Up to 2 weeks after dosing
Aldosterone suppression	Serum aldosterone concentration	Up to 48 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (Plasma DP13 concentration)	Plasma DP13 concentration	up to 48 hours after dosing
Pharmacodynamic selectivity (Plasma hormone concentrations)	Plasma hormone concentrations	Up to 48 hours after dosing

Collaborators and Investigators

• Sponsor: Damian Pharma AG
• Collaborators: University Hospital Inselspital, Berne; Covance; Foundation for Therapeutic Research, Lausanne

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2017
• Primary Completion (ACTUAL): March 14, 2018
• Study Completion (ACTUAL): March 27, 2018

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (ESTIMATE): February 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DP13C101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No