DP13 SAD & MAD in Healthy Male Subjects

NCT03046589 | Completed Phase 1

• 1 other identifier: DP13C101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects
2. 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
3. 3.To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male subjects
4. 4.To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male subjects

Conditions

Safety and Tolerability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pharmacokinetics (Plasma DP13 concentration)

  up to 48 hours after dosing

• Pharmacodynamic selectivity (Plasma hormone concentrations)

  Up to 48 hours after dosing

Study Arms (6)

Treatment Period 1

EXPERIMENTAL

DP13 capsules (dose level 1 ) and placebo capsules

Drug: DP13; Drug: placebo

Treatment Period 2

EXPERIMENTAL

DP13 capsules (dose level 2) and placebo capsules

Drug: DP13; Drug: placebo

Treatment Period 3

EXPERIMENTAL

DP13 capsules (dose level 3) and placebo capsules

Drug: DP13; Drug: placebo

Treatment Period 4

EXPERIMENTAL

DP13 capsules (dose level 4) and placebo capsules

Drug: DP13; Drug: placebo

Treatment Period 5

EXPERIMENTAL

DP13 capsules (dose level 5) and placebo capsules

Drug: DP13; Drug: placebo

Treatment Period 6

EXPERIMENTAL

DP13 capsules (dose level 6) and placebo capsules

Drug: DP13; Drug: placebo

Interventions

DP13 DRUG

dose escalation

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4; Treatment Period 5; Treatment Period 6

placebo DRUG

control to dose-escalation

Treatment Period 1; Treatment Period 2; Treatment Period 3; Treatment Period 4; Treatment Period 5; Treatment Period 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damian Pharma AG: lead
• Covance: collaborator
• Foundation for Therapeutic Research, Lausanne: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

Related Publications (1)

• Mulatero P, Groessl M, Vogt B, Schumacher C, Steele RE, Brooks A, Hossack S, Brunner HR. CYP11B2 inhibitor dexfadrostat phosphate suppresses the aldosterone-to-renin ratio, an indicator of sodium retention, in healthy volunteers. Br J Clin Pharmacol. 2023 Aug;89(8):2483-2496. doi: 10.1111/bcp.15713. Epub 2023 Apr 10.

  PMID: 36914591 DERIVED

Study Officials

• Ashley Brooks, MBChB

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 8, 2017
• Study Start: March 6, 2017
• Primary Completion: March 14, 2018
• Study Completion: March 27, 2018
• Last Updated: April 17, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)