Safety and TolerabilityPhase 1NCT03046589

DP13 SAD & MAD in Healthy Male Subjects

A Phase 1 study testing DP13 in people with Safety and Tolerability, run by Damian Pharma AG at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Safety and Tolerability
What is being tested?: DP13
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Mar 2017to 27 Mar 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit Ltd
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: 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:

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

Conditions: Safety and Tolerability
Being tested: DP13, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DP13Drug
dose escalation
placeboDrug
control to dose-escalation

Study groups in NCT03046589
Study group	Role	What they receive
Treatment Period 1	Experimental	DP13 capsules (dose level 1 ) and placebo capsules Receives: Drug: DP13; Drug: placebo
Treatment Period 2	Experimental	DP13 capsules (dose level 2) and placebo capsules Receives: Drug: DP13; Drug: placebo
Treatment Period 3	Experimental	DP13 capsules (dose level 3) and placebo capsules Receives: Drug: DP13; Drug: placebo
Treatment Period 4	Experimental	DP13 capsules (dose level 4) and placebo capsules Receives: Drug: DP13; Drug: placebo
Treatment Period 5	Experimental	DP13 capsules (dose level 5) and placebo capsules Receives: Drug: DP13; Drug: placebo
Treatment Period 6	Experimental	DP13 capsules (dose level 6) and placebo capsules Receives: Drug: DP13; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability (Clinical signs and symptoms incl ECG, vital signs, electrolytes)
Clinical signs and symptoms incl ECG, vital signs, electrolytes
Measured: Up to 2 weeks after dosing
Aldosterone suppression
Serum aldosterone concentration
Measured: Up to 48 hours after dosing

Secondary outcomes (2)

Pharmacokinetics (Plasma DP13 concentration)
Plasma DP13 concentration
Measured: up to 48 hours after dosing
Pharmacodynamic selectivity (Plasma hormone concentrations)
Plasma hormone concentrations
Measured: Up to 48 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201727 Mar 2018

First posted8 Feb 2017 (estimated)
Study start6 Mar 2017
Primary completion14 Mar 2018
Study completion27 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Safety and TolerabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03046589
Sponsor's protocol ID: DP13C101
Status last verified: Jul 2017
First submitted: 5 Feb 2017
Last updated: 17 Apr 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36914591

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

All Safety and Tolerability trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03046589
Acronym / sponsor ID: DP13C101
Conditions: Safety and Tolerability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Damian Pharma AGIndustry (pharma, biotech, devices)
Collaborators: Covance, Foundation for Therapeutic Research, Lausanne, Insel Gruppe AG, University Hospital Bern
Study start: 6 Mar 2017 (actual)
Primary completion: 14 Mar 2018 (actual)
Study completion: 27 Mar 2018 (actual)
First posted: 8 Feb 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Treatment Period 1	Experimental	Drug: DP13, Drug: placeboDP13 capsules (dose level 1 ) and placebo capsules
Treatment Period 2	Experimental	Drug: DP13, Drug: placeboDP13 capsules (dose level 2) and placebo capsules
Treatment Period 3	Experimental	Drug: DP13, Drug: placeboDP13 capsules (dose level 3) and placebo capsules
Treatment Period 4	Experimental	Drug: DP13, Drug: placeboDP13 capsules (dose level 4) and placebo capsules
Treatment Period 5	Experimental	Drug: DP13, Drug: placeboDP13 capsules (dose level 5) and placebo capsules
Treatment Period 6	Experimental	Drug: DP13, Drug: placeboDP13 capsules (dose level 6) and placebo capsules

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DP13dose escalation	Drug	Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4, Treatment Period 5, Treatment Period 6
placebocontrol to dose-escalation	Drug	Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4, Treatment Period 5, Treatment Period 6

Primary outcome

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

2 secondary outcomes

Pharmacokinetics (Plasma DP13 concentration)
Time frame: up to 48 hours after dosing
Pharmacodynamic selectivity (Plasma hormone concentrations)
Time frame: Up to 48 hours after dosing

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Derived from this study: PubMed 36914591Mulatero 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.
Individual participant dataSharing planned: No

Related trials for Safety and Tolerability

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ashley Brooks, MBChB principal investigator

Covance

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DP13 in people with Safety and Tolerability, run by Damian Pharma AG at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (Clinical signs and symptoms incl ECG, vital signs, electrolytes) (time frame: Up to 2 weeks after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03046589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.