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PharmacodynamicPhase 1NCT06649409

Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

A Phase 1 study testing Vamorolone, Eplerenone and Fludrocortisone in people with Pharmacodynamic, run by Santhera Pharmaceuticals at 1 site in Germany.

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

To evaluate if the trial drug vamorolone is able to block a specific receptor in the body called mineralocorticoid receptor. This receptor helps to regulate salt and water balance. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pharmacodynamic
What is being tested?
Vamorolone, Eplerenone and Fludrocortisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
5 Jun 2024to 6 Jul 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age of 18 to 55 years inclusive, at the time of signing the informed consent.
  • Male is overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests and ECG.
  • Body weight ≥ 50 kg and a BMI ≥ 18 kg/m2 and ≤ 29.9 kg/m2 at screening
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • If the subject is a sexually active man and not surgically sterilized, he must be willing to:
  • Abstain from sexual intercourse or
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  • Use a condom plus another form of contraception (e.g., spermicide, Intrauterine device (IUD), birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant.
  • Use a condom during sexual intercourse with pregnant or lactating women.
  • Must not father a child and must refrain from donating sperm from administration of the first dose and up to 3 months after the last dose of study treatment.
  • Subject is a non-smoker for at least 3 months prior to exposure to the study treatments.
  • Subjects must also have abstained from use of other nicotine containing products (e.g., nicotine patch, chewing gum or e-cigarettes) for at least 3 months before exposure to the study treatment.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol prior to any clinical study specific procedure.
  • Supine systolic blood pressure of ≥ 90 mmHg and ≤ 140 mmHg, diastolic blood pressure of ≥ 50 mmHg and ≤ 90 mmHg, pulse rate of ≥ 45 bpm and ≤ 90 bpm, and tympanic body temperature of ≥ 35.0 and ≤ 37.5°C at screening.
  • Subjects must be able to communicate well with the Investigator and comply with the protocol requirements, instructions, and protocol related restrictions (e.g., dietary, fluid and lifestyle restrictions from screening to study completion)
  • Subjects must be able to swallow the study treatments as per protocol

Who cannot join

  • A past medical history of clinically significant abnormalities or a history/family history of long QT interval syndrome.
  • An abnormal ECG, defined as:
  • Pulse rate (PR) > 215 msec and < 120 msec, QRS (Part of electrocardiographic wave representing ventricular depolarization) complex > 120 msec; QTcF > 440 msec by automated reading
  • Any clinically significant cardiac conduction abnormalities
  • Any atrial or ventricular arrhythmias
  • A past medical history of myocardial infarction, angina pectoris, atherosclerosis, or other clinically significant heart disease (e.g.congestive heart failure, uncontrolled hypertension, history of labile hypertension)
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  • A past medical history of peptic ulcers, diverticulitis, and non-specific ulcerative colitis.
  • History of complaints of frequent dizziness and /or vomiting spells or lightheadedness.
  • Any history or evidence of any clinically relevant, gastrointestinal, respiratory, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, genitourinary, pulmonary, neurologic, dermatologic, musculoskeletal, and/or other major disease or malignancy as determined by medical evaluation (including physical examination) capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatments; or interfering with the interpretation of data.
  • Known Gilbert's syndrome.
  • Any clinically relevant history of allergic conditions requiring hospitalization or prolonged systemic treatment (including drug allergies, allergic asthma, eczema, allergies requiring therapy with corticosteroids or anaphylactic reactions); but excluding untreated, asymptomatic, seasonal allergies at time of dosing or allergic contact sensitizations (e.g., nickel allergy).
  • Known or suspected hypersensitivity or contraindications to the study treatments or any components of the formulation used, e.g., vamorolone, eplerenone and fludrocortisone.
  • Relevant current acute or chronic/recurrent viral, bacterial, fungal or parasitic infections (e.g., pulmonary/upper respiratory, gastrointestinal, urinary, skin, or ear, nose and throat (ENT) infections) at screening or within 28 days prior to administration of the study treatments.
  • Use of any concomitant medication or any drugs / medicines (including dietary supplements, natural and herbal remedies, and hormone replacement therapy) within 2 weeks or 5 times the half-life of the respective drug, whichever is longer, prior to the first administration of the study treatments.
  • Occasional use of paracetamol up to 2 g/day (medicinal product in its original packaging, approved and marketed in Germany) is permitted.
  • Oral, injectable, and implantable contraceptives as outlined in protocol section 5.1 are permitted.
  • Previous exposure to vamorolone.
  • Any use of corticoids within 6 months prior to the first administration of the study treatments.
  • Administration of live, attenuated, replication-competent vaccines within 6 weeks prior to the first administration of study treatment until 2 weeks after the follow-up visit. Administration of inactivated vaccines or vector-based or messenger ribonucleic acid (mRNA ) COVID-19 vaccines within 2 weeks prior to the first administration of the study treatments until 2 weeks after the follow-up visit.
  • Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the first administration of the study treatments.
  • Use of any investigational drug or participation in any clinical study within 30 days or 5 half-lives (whichever is longer) prior to the expected date of first administration of study treatments or planning to take other investigational drugs during the study.
  • Positive results for HBsAg, anti-HCV (Hepatitis C virus), anti-HIV 1 and 2, and HIV 1-p24 antigen at screening.
  • Positive screen for alcohol, drugs of abuse and cotinine at screening.
  • Elevations in Alanine aminotransferase (ALT) ≥ 1.1 x ULN (Upper limit of normal) , AST (Aspartate aminotransferase) ≥ 1.1 x ULN, serum bilirubin ≥ 1.0 x ULN, creatinine ≥1.0 x ULN and HbA1c > ULN at screening. A case-by-case decision for any abnormality must be discussed with the Sponsor before inclusion.
  • Sodium, potassium, magnesium, chloride blood concentration below the lower limit of normal at screening.
  • Thyroid-stimulating hormone (TSH) and coagulation outside of normal ranges.
  • eGFR (Estimated glomerular filtration rate) based on the Chronic kidney disease epidemiology collaboration (CKD-EPI) of < 90 mL/min at screening.
  • Subjects who are unwilling to adhere to contraceptive requirements.
  • Higher than low-risk alcohol consumption i.e., consumption of an average weekly alcohol intake of > 21 units/week for men. 1 unit (12 g) corresponds to 0.3 L of beer/day or 0.12 L of wine/day or 1 glass (at 2 cL) of spirits/day.
  • Excessive consumption of caffeine- or xanthine-containing food or beverages (> 5 cups of coffee a day or equivalent) or inability to stop consuming from 48 hours prior to first planned administration of study treatments.
  • Consumption of alcohol from 48 hours prior to admission
  • Consumption of high-dose resveratrol-containing products or products with enzyme-inducing or enzyme-inhibiting properties 14 days prior to first administration of study treatments.
  • Regular consumption of poppy seed containing food prior to first administration of study treatments.
  • No sweets/teas containing liquorice are allowed within 2 weeks prior to first administration of study treatments up to the follow-up examination.
  • Any use of drugs-of-abuse or alcohol abuse within 1 month prior to dosing.
  • Subject with vegetarian, vegan, or restricted diet (e.g., gluten-free) or not willing or able to eat the complete standard meals.
  • Donation or loss of more than 400 mL of blood or received a transfusion of any blood or blood products within 30 days, or donated plasma within 30 days prior to first administration of study treatments.
  • Strenuous physical activity within 72 h to admission.
  • Employee of the Sponsor, the Nuvisan Group, or other Contract Research Organization involved in the clinical study.
  • Legal incapacity or limited legal capacity, or incarceration and vulnerable subjects.
  • Inability to understand or communicate reliably with the Investigator or considered by the Investigator to be unable to or unlikely to co-operate with the protocol requirements, instructions, and study-related restrictions
  • History of non-compliance to medical regimens and subjects who are considered potentially unreliable (e.g., refuse to comply with study regulations).
  • Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.
  • Changes in medical conditions compared to screening, as judged by the Investigator.
  • Body weight < 50 kg.
  • Changes in prior/concomitant therapy compared to screening, as judged by the Investigator.
  • Positive for an acute common cold/respiratory or other infection upon admission.
  • Positive screen for alcohol, drugs of abuse and cotinine test upon admission.
  • Changes in other exclusion criteria compared to screening, as judged by the Investigator.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Nuvisan GmbH

    Neu-Ulm, 89231

Other trials in Germany

About this study

Official title: An Open-label, Randomized, 3-arm, Parallel-group, Positive- and Negative-arm Controlled Study to Evaluate the Mineralocorticoid Receptor Antagonism Effect of Vamorolone in Healthy Subjects

To evaluate if the trial drug vamorolone is able to block a specific receptor in the body called mineralocorticoid receptor. This receptor helps to regulate salt and water balance.

Read the detailed description

The purpose of this study is to investigate the antagonistic effect of vamorolone on the mineralocorticoid receptor following mineralocorticoid challenge by fludrocortisone, compared to eplerenone as a positive control, and to a negative control with no study treatment. Furthermore, the safety and tolerability of vamorolone combined with fludrocortisone challenge will be assessed, and the Pharmacokinetic (PK) of a single dose of vamorolone and a single dose of eplerenone, combined with fludrocortisone challenge, will be evaluated.

Conditions
Pharmacodynamic
Being tested
Vamorolone, Eplerenone, Fludrocortisone
Keywords
Mineralocorticoid Receptor Antagonism

What participants receive

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

  • VamoroloneDrug

    Also called experimental drug

    vamorolone 20 mg/kg single dose on Day 2

  • EplerenoneDrug

    Also called positive control

    Eplerenone 200 mg single dose on Day 2

  • FludrocortisoneDrug

    Also called auxiliary medicinal product - mineralocorticoid agonist

    Fludrocortisone challenge on Days 1 to 3 (for all subjects):

    Day 1:

    -Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm

    Day 2:

    • Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
    • Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
    • Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.

    Day 3:

    -Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.

Study groups in NCT06649409
Study groupRoleWhat they receive
Study arm 1 vamoroloneExperimentalVamorolone 20 mg/kg single dose on Day 2 and Fludrocortisone challenge on Days 1 to 3
Receives: Drug: Vamorolone; Drug: Fludrocortisone
Study arm 2 (positive control arm): eplerenoneActive comparatorEplerenone 200 mg single dose on Day 2 and Fludrocortisone challenge on Days 1 to 3
Receives: Drug: Eplerenone; Drug: Fludrocortisone
Study arm 3 (negative control arm): no "active" treatmentOtherFludrocortisone challenge on Days 1 to 3
Receives: Drug: Fludrocortisone

What is being measured

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

  1. Determination of the Ratio of Sodium to Potassium (Na/K) in Urine

    Amounts of Na and K were calculated by multiplying the respective concentration by the volume of urine for each collection interval. The considered timepoints were:

    Day 1: 24-9 h and 9-0 h predose of vamorolone/eplerenone; Day 2: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h, 12-14 h, 14-16 h, 16-24 h postdose vamorolone/eplerenone or corresponding timepoint for negative control arm with fludrocortisone administrations (no treatment) Day 3: 24-32 h, 32-40 h, 40-48 h postdose vamorolone/eplerenone or corresponding timepoint for negative control arm with fludrocortisone administrations (no treatment)

    The individual Na/K ratio was then calculated for each urine collection interval using the amounts of Na and K. The corresponding logarithm of the Na/K ratio was determined. To avoid negative values, the ratio was multiplied by 10 before transformation, i.e., log10(10*Na/K).

    Measured: Day 1, Day 2 and Day 3

Secondary outcomes (10)

  1. Vamorolone PK Parameter AUC0-tlast

    The area under the concentration-time curve (AUC) from time zero (= dosing time) to the time of the last quantifiable concentration (tlast). The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  2. Vamorolone PK Parameter AUC0-inf

    The AUC from time zero (dosing time) extrapolated to infinity estimated. The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  3. Vamorolone PK Parameter Cmax

    Maximum plasma drug concentration after administration of vamorolone. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  4. Vamorolone PK Parameter Tmax

    Time to reach maximum concentration following vamorolone administration. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  5. Vamorolone PK Parameter t1/2

    Elimination half-life is the amount of time it takes for the concentration of a drug in the body to decrease by half. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  6. Eplerenone PK Parameters AUC0-tlast

    The area under the concentration-time curve (AUC) from time zero (= dosing time) to the time of the last quantifiable concentration (tlast).The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  7. Eplerenone PK Parameter AUC0-inf

    The AUC from time zero (dosing time) extrapolated to infinity. The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  8. Eplerenone PK Parameter Cmax

    Maximum plasma drug concentration after administration of eplerenone. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  9. Eplerenone PK Parameter Tmax

    Time to reach to the maximum concentration after eplerenone. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

  10. Eplerenone PK Parameter t1/2

    Elimination half-life is the amount of time it takes for the concentration of a drug in the body to decrease by half. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2

    Measured: Day 2

Timeline

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

  1. First posted18 Oct 2024
  2. Study start5 Jun 2024
  3. Primary completion29 Jun 2024
  4. Study completion6 Jul 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be conducted in a single-center, randomized, open-label, 3-arm, parallel-group, positive- and negative-controlled design.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06649409
Sponsor's protocol ID
SNT-I-VAM-026
Other IDs
2024-512101-60-00, N-A-PH1-23-067
Status last verified
Aug 2025
First submitted
5 Sep 2024
Last updated
11 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Vera A, Clemens PR, Dang UJ, Dutreix C, Gresko E, Guglieri M, Hagerty L, Hasham S, Damsker J, Hathout Y, Linden A, Berglund A, Tobin R, Wahbi K, Hoffman EP. Mineralocorticoid receptor antagonism of vamorolone: Evidence from LIONHEART and VISION-DMD clinical trials. Steroids. 2025 Nov;223:109689. doi: 10.1016/j.steroids.2025.109689. Epub 2025 Sep 14.

    PubMed 40957504

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vamorolone, Eplerenone and Fludrocortisone in people with Pharmacodynamic, run by Santhera Pharmaceuticals at 1 site in Germany.

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 15 inclusion and 49 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 11 Sep 2025. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Determination of the Ratio of Sodium to Potassium (Na/K) in Urine (time frame: Day 1, Day 2 and Day 3). 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 NCT06649409, 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 11 Sep 2025.

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