Trial | NCT03046589  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dp13 ...

  • Study Participants

    48
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
Study Started
Mar 06
2017
Primary Completion
Mar 14
2018
Study Completion
Mar 27
2018
Last Update
Apr 17
2018

Drug DP13

dose escalation

Drug placebo

control to dose-escalation

Treatment Period 4 Experimental

DP13 capsules (dose level 4) and placebo capsules

Treatment Period 5 Experimental

DP13 capsules (dose level 5) and placebo capsules

Treatment Period 6 Experimental

DP13 capsules (dose level 6) and placebo capsules

Treatment Period 1 Experimental

DP13 capsules (dose level 1 ) and placebo capsules

Treatment Period 2 Experimental

DP13 capsules (dose level 2) and placebo capsules

Treatment Period 3 Experimental

DP13 capsules (dose level 3) and placebo capsules

Criteria 

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
No Results Posted