DP13 SAD & MAD in Healthy Male Subjects

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Safety and Tolerability

Intervention / Treatment
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* Drug: DP13
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Period 1<br>DP13 capsules (dose level 1 ) and placebo capsules | Drug: DP13<br>* dose escalation<br>Drug: placebo<br>* control to dose-escalation<br>|
| Experimental: Treatment Period 2<br>DP13 capsules (dose level 2) and placebo capsules | Drug: DP13<br>* dose escalation<br>Drug: placebo<br>* control to dose-escalation<br>|
| Experimental: Treatment Period 3<br>DP13 capsules (dose level 3) and placebo capsules | Drug: DP13<br>* dose escalation<br>Drug: placebo<br>* control to dose-escalation<br>|
| Experimental: Treatment Period 4<br>DP13 capsules (dose level 4) and placebo capsules | Drug: DP13<br>* dose escalation<br>Drug: placebo<br>* control to dose-escalation<br>|
| Experimental: Treatment Period 5<br>DP13 capsules (dose level 5) and placebo capsules | Drug: DP13<br>* dose escalation<br>Drug: placebo<br>* control to dose-escalation<br>|
| Experimental: Treatment Period 6<br>DP13 capsules (dose level 6) and placebo capsules | Drug: DP13<br>* dose escalation<br>Drug: placebo<br>* control to dose-escalation<br>|

What is the study measuring?
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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 |