DP13 SAD & MAD in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-03-27

Brief Summary

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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

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Detailed Description

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Conditions

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Safety and Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment Period 1

DP13 capsules (dose level 1 ) and placebo capsules

Group Type EXPERIMENTAL

DP13

Intervention Type DRUG

dose escalation

placebo

Intervention Type DRUG

control to dose-escalation

Treatment Period 2

DP13 capsules (dose level 2) and placebo capsules

Group Type EXPERIMENTAL

DP13

Intervention Type DRUG

dose escalation

placebo

Intervention Type DRUG

control to dose-escalation

Treatment Period 3

DP13 capsules (dose level 3) and placebo capsules

Group Type EXPERIMENTAL

DP13

Intervention Type DRUG

dose escalation

placebo

Intervention Type DRUG

control to dose-escalation

Treatment Period 4

DP13 capsules (dose level 4) and placebo capsules

Group Type EXPERIMENTAL

DP13

Intervention Type DRUG

dose escalation

placebo

Intervention Type DRUG

control to dose-escalation

Treatment Period 5

DP13 capsules (dose level 5) and placebo capsules

Group Type EXPERIMENTAL

DP13

Intervention Type DRUG

dose escalation

placebo

Intervention Type DRUG

control to dose-escalation

Treatment Period 6

DP13 capsules (dose level 6) and placebo capsules

Group Type EXPERIMENTAL

DP13

Intervention Type DRUG

dose escalation

placebo

Intervention Type DRUG

control to dose-escalation

Interventions

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DP13

dose escalation

Intervention Type DRUG

placebo

control to dose-escalation

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes