Healthy VolunteersPhase 1DACORSIN/4NCT04791345
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls
A Phase 1 study testing Methylprednisone, Deflazacort and Dexamethasone in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Background: Glucocorticoids (GC) were included in the list of banned substances in sports in 1986, because of evidences of positive effects on physical performance and the important health risks associated with its consumption. 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
- Healthy Volunteers
- What is being tested?
- Methylprednisone, Deflazacort and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2021to 26 Feb 2022
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers aged between 18 and 55 years.
- Able to understand and accept the trial procedures and able to sign an informed consent prior to any study-mandated procedure.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed before the experimental session within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified in writing.
- Body mass index (weight/height^2) between 19 and 27 kg/m2 and weight between 50 and 100 kg. BMI of 27-28 kg/m2 may be included according to Principal Investigator's criteria.
Who cannot join
- Failure to meet inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to glucocorticoids or any of the excipients. Serious adverse reactions to any drug.
- Contraindications to treatment with study drugs (according to the respective summary of product characteristics, SmPC).
- Clinical background or evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug.
- Clinical background or evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
- Having participated in another clinical trial with medication in the three months prior to the start of the study.
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- Having donated blood in the three months prior to the start of the study, in the event that blood extractions are made.
- Having suffered some organic disease or major surgery in the six months prior to the start of the study.
- Clinical background or evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may pose a risk to the subjects or may interfere with the objectives of the study. Especially osteoporosis, hypertension, Cushing syndrome, diabetes mellitus, and viral infections such as herpes or varicella.
- Having taken medication regularly in the month prior to the study sessions -in case of glucocorticoids 3 months prior- with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may not pose a risk to the subjects or may not interfere with the objectives of the study. Treatment with a single dose of symptomatic medication in the week prior to the study sessions will not be a reason for exclusion if it is assumed that the drug has been completely eliminated on the day of the experimental session.
- Smokers of more than 20 cigarettes a day in the 3 months before the study.
- Consumption of more than 40 g of alcohol daily.
- Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the study start.
- Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
- Positive serology for hepatitis B, C or HIV.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, 08003
Ana M Aldea Perona, MD, PhD, +34933160490, aaldea@imim.es
Ana M Aldea Perona, MD, PhD
About this study
Background:
Glucocorticoids (GC) were included in the list of banned substances in sports in 1986, because of evidences of positive effects on physical performance and the important health risks associated with its consumption.
Read more
Due to the fact that GC are commercialized in a variety of pharmaceutical forms and are administered in different ways, it is necessary to establish discrimination criteria to guarantee the therapeutic use of these drugs and to prevent doping.
Hypothesis:
Discrimination criteria between allowed and prohibited administrations of GC must be specific for each of the compounds. Further studies are needed to provide discrimination criteria related to oral administration of GC.
Objectives:
To conduct excretion studies with dexamethasone, methylprednisolone and deflazacort in order to define notification levels and wash-out periods after the administration of a single dose (DEX, MP and DEF) or repeated doses (DEX and MP) of these drugs.
Methods:
Non-randomized, open-label, pharmacokinetics clinical trial where a single dose of DEF, MP and DEX and also a multi-dose of DEX and MP will be administered orally to healthy volunteers (total n=50).
Read the detailed description
The World Anti-Doping Agency (WADA) has established a general notification level of 30 ng/mL for GC to discriminate allowed and not allowed administrations. However, recent studies have proven that the use of a unique criteria is not adequate given the diversity of administration routes, doses and pharmacokinetics and pharmacodynamics properties of each drug.
The goal of this study is to conduct additional studies using dexamethasone (DEX), methylprednisolone (MP) and deflazacort (DEF) in order to generate additional data of urinary concentrations and wash-out periods after single and repeated oral doses of these drugs.
- Conditions
- Healthy Volunteers
- Being tested
- Methylprednisone, Deflazacort, Dexamethasone
- Keywords
- Anti-doping control, Glucocorticoids, Corticosteroids, Dexamethasone, Methylprednisolone, Deflazacort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylprednisoneDrug
Also called Urbason®
12 mg of methylprednisone (3 pills of 4 mg each) administered orally in a single dose.
MethylprednisoneDrug
Also called Urbason®
12 mg of methylprednisone (3 pills of 4 mg each) administered orally every 24 hours during 3 days.
DeflazacortDrug
30 mg of deflazacort (1 pill) administered orally in a single dose.
DexamethasoneDrug
4 mg of dexamethasone (1 pill) administered orally in a single dose.
DexamethasoneDrug
2 mg of dexamethasone (1/2 pill) administered orally every 12 hours during 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisone single-dose | Experimental | Subjects receive a single dose treatment. Urine samples will be collected until 5 days after administration in 10 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration. Blood samples will be collected until 6 days after administration in 5 fractions: pre-administration and 24h, 48h, 72h and 120h post-administration. Receives: Drug: Methylprednisone |
| Methylprednisone multiple-dose | Experimental | Subjects receive a multiple dose treatment. Urine samples will be collected until 7 days after administration in 20 fractions. Receives: Drug: Methylprednisone |
| Deflazacort single-dose | Experimental | Subjects receive a single-dose treatment. Urine samples will be collected until 5 days after administration in 10 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration. Blood samples will be collected until 6 days after administration in 5 fractions: pre-administration and 24h, 48h, 72h and 120h post-administration. Receives: Drug: Deflazacort |
| Dexamethasone single-dose | Experimental | Subjects receive a single-dose treatment. Urine samples will be collected until 13 days after administration in 11 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h, 120-144h post-administration.
Blood samples will be collected until 9 days after administration in 6 fractions: pre-administration and 24h, 48h, 72h, 120h and 192h post-administration. Receives: Drug: Dexamethasone |
| Dexamethasone multiple-dose | Experimental | Subjects receive a multiple dose treatment. Urine samples will be collected until 10 days after administration in 34 fractions. Blood samples will be collected until 13 days after the first administration. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of methylprednisone
Concentration of methylprednisone in each fraction of urine samples
Measured: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Urine concentration of methylprednisone metabolites
Concentration of methylprednisone metabolites in each fraction of urine samples
Measured: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Urine concentrations of deflazacort
Concentration of deflazacort in each fraction of urine samples
Measured: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Urine concentrations of deflazacort metabolites
Concentration of deflazacort metabolites in each fraction of urine samples
Measured: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Urine concentration of dexamethasone
Concentration of dexamethasone in each fraction of urine samples
Measured: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h, 120-144h post-administration
Urine concentration of dexamethasone metabolites
Concentration of dexamethasone metabolites in each fraction of urine samples
Measured: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h, 120-144h post-administration
Secondary outcomes (23)
Plasma concentrations of drug metabolites
Concentrations of drug metabolites (DEX, MP, DEF) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of cortisol
Concentrations of cortisol in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of endogen steroids
Concentrations of endogen steroids in plasma [testosterone (T), epitestosterone (E), androsterone (A), etiocholanolone (Etio), 5α-androstane-3α,17β-diol (5aAdiol), 5β-androstane-3α,17β-diol (5bAdiol), and the quotients T/E, A/T, A/Etio, 5aAdiol/5bAdiol and 5aAdiol/ET]
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of testosterone
Concentrations of testosterone in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of epitestosterone
Concentrations of epitestosterone in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of androsterone
Concentrations of androsterone in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of etiocholanolone
Concentrations of etiocholanolone (Etio) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of 5α-androstane-3α,17β-diol
Concentrations of 5α-androstane-3α,17β-diol (5aAdiol) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of 5β-androstane-3α,17β-diol
Concentrations of 5β-androstane-3α,17β-diol (5bAdiol) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient testosterone/epitestosterone in plasma
Concentrations of testosterone/epitestosterone (T/E) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient androsterone/testosterone in plasma
Concentrations of androsterone/testosterone (A/T) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient androsterone/Etio in plasma
Concentrations of androsterone/etiocholanolone (A/Etio) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient 5aAdiol/5bAdiol in plasma
Concentrations of 5α-androstane-3α,17β-diol/5β-androstane-3α,17β-diol (5aAdiol/5bAdiol) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient 5aAdiol/ET in plasma
Concentrations of 5α-androstane-3α,17β-diol/etiocholanolone (5aAdiol/ET) in plasma
Measured: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Hemoglobin concentration
Variation of hemoglobin concentrations in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Hematocrit
Variation of hematocrit value in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Mean corpuscular hemoglobin
Variation of mean corpuscular hemoglobin (MCH) levels in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Mean corpuscular volume of erythrocytes
Variation of mean corpuscular volume of erythrocytes (MCV) levels in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Erythrocytes count
Variation of erythrocytes count in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Standard deviation of the range of distribution of erythrocytes
Variation of standard deviation of the range of distribution of erythrocytes
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Platelet count
Variation of platelet count in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Reticulocyte count
Variation of reticulocyte count in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Fraction of immature reticulocytes
Variation of immature reticulocytes fraction in blood
Measured: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start26 Feb 2021
- Primary completion26 Feb 2022 (estimated)
- Study completion26 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, non-randomized, open-label clinical trial in healthy male volunteers. A single dose of DEX, MP and DEF, and multiple dose of DEX and MP will be administered to different subjects.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Ventura Alemany, PharmD, PhD, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)Ana M Aldea Perona, MD, PhD, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791345
- Sponsor's protocol ID
- IMIMFTCL/DACORSIN/4
- Acronym
- DACORSIN/4
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls
- ClinicalTrials.gov ID
- NCT04791345
- Acronym / sponsor ID
- DACORSIN/4 / IMIMFTCL/DACORSIN/4
- Conditions
- Healthy Volunteers
- Keywords
- Anti-doping control, Glucocorticoids, Corticosteroids, Dexamethasone, Methylprednisolone, Deflazacort
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 26 Feb 2022 (estimated)
- Study completion
- 26 Feb 2022 (estimated)
- First posted
- 10 Mar 2021 (actual)
- 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.
Background:
Glucocorticoids (GC) were included in the list of banned substances in sports in 1986, because of evidences of positive effects on physical performance and the important health risks associated with its consumption.
Due to the fact that GC are commercialized in a variety of pharmaceutical forms and are administered in different ways, it is necessary to establish discrimination criteria to guarantee the therapeutic use of these drugs and to prevent doping.
Hypothesis:
Discrimination criteria between allowed and prohibited administrations of GC must be specific for each of the compounds. Further studies are needed to provide discrimination criteria related to oral administration of GC.
Objectives:
To conduct excretion studies with dexamethasone, methylprednisolone and deflazacort in order to define notification levels and wash-out periods after the administration of a single dose (DEX, MP and DEF) or repeated doses (DEX and MP) of these drugs.
Methods:
Non-randomized, open-label, pharmacokinetics clinical trial where a single dose of DEF, MP and DEX and also a multi-dose of DEX and MP will be administered orally to healthy volunteers (total n=50).
Detailed description
The World Anti-Doping Agency (WADA) has established a general notification level of 30 ng/mL for GC to discriminate allowed and not allowed administrations. However, recent studies have proven that the use of a unique criteria is not adequate given the diversity of administration routes, doses and pharmacokinetics and pharmacodynamics properties of each drug.
The goal of this study is to conduct additional studies using dexamethasone (DEX), methylprednisolone (MP) and deflazacort (DEF) in order to generate additional data of urinary concentrations and wash-out periods after single and repeated oral doses of these drugs.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Single-center, non-randomized, open-label clinical trial in healthy male volunteers. A single dose of DEX, MP and DEF, and multiple dose of DEX and MP will be administered to different subjects.
| Arm | Type | Receives |
|---|---|---|
| Methylprednisone single-dose | Experimental | Drug: MethylprednisoneSubjects receive a single dose treatment. Urine samples will be collected until 5 days after administration in 10 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration. Blood samples will be collected until 6 days after administration in 5 fractions: pre-administration and 24h, 48h, 72h and 120h post-administration. |
| Methylprednisone multiple-dose | Experimental | Drug: MethylprednisoneSubjects receive a multiple dose treatment. Urine samples will be collected until 7 days after administration in 20 fractions. |
| Deflazacort single-dose | Experimental | Drug: DeflazacortSubjects receive a single-dose treatment. Urine samples will be collected until 5 days after administration in 10 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration. Blood samples will be collected until 6 days after administration in 5 fractions: pre-administration and 24h, 48h, 72h and 120h post-administration. |
| Dexamethasone single-dose | Experimental | Drug: DexamethasoneSubjects receive a single-dose treatment. Urine samples will be collected until 13 days after administration in 11 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h, 120-144h post-administration. Blood samples will be collected until 9 days after administration in 6 fractions: pre-administration and 24h, 48h, 72h, 120h and 192h post-administration. |
| Dexamethasone multiple-dose | Experimental | Drug: DexamethasoneSubjects receive a multiple dose treatment. Urine samples will be collected until 10 days after administration in 34 fractions. Blood samples will be collected until 13 days after the first administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers aged between 18 and 55 years.
- Able to understand and accept the trial procedures and able to sign an informed consent prior to any study-mandated procedure.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed before the experimental session within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified in writing.
- Body mass index (weight/height^2) between 19 and 27 kg/m2 and weight between 50 and 100 kg. BMI of 27-28 kg/m2 may be included according to Principal Investigator's criteria.
Key exclusion criteria (15 listed)
- Failure to meet inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to glucocorticoids or any of the excipients. Serious adverse reactions to any drug.
- Contraindications to treatment with study drugs (according to the respective summary of product characteristics, SmPC).
- Clinical background or evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug.
- Clinical background or evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
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 |
|---|---|---|
| MethylprednisoneAlso: Urbason®12 mg of methylprednisone (3 pills of 4 mg each) administered orally in a single dose. | Drug | Methylprednisone single-dose |
| MethylprednisoneAlso: Urbason®12 mg of methylprednisone (3 pills of 4 mg each) administered orally every 24 hours during 3 days. | Drug | Methylprednisone multiple-dose |
| Deflazacort30 mg of deflazacort (1 pill) administered orally in a single dose. | Drug | Deflazacort single-dose |
| Dexamethasone4 mg of dexamethasone (1 pill) administered orally in a single dose. | Drug | Dexamethasone single-dose |
| Dexamethasone2 mg of dexamethasone (1/2 pill) administered orally every 12 hours during 5 days. | Drug | Dexamethasone multiple-dose |
Primary outcome
Urine concentration of methylprednisone
Time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Concentration of methylprednisone in each fraction of urine samples
Urine concentration of methylprednisone metabolites
Time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Concentration of methylprednisone metabolites in each fraction of urine samples
Urine concentrations of deflazacort
Time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Concentration of deflazacort in each fraction of urine samples
Urine concentrations of deflazacort metabolites
Time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration
Concentration of deflazacort metabolites in each fraction of urine samples
Urine concentration of dexamethasone
Time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h, 120-144h post-administration
Concentration of dexamethasone in each fraction of urine samples
Urine concentration of dexamethasone metabolites
Time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h, 120-144h post-administration
Concentration of dexamethasone metabolites in each fraction of urine samples
23 secondary outcomes
Plasma concentrations of drug metabolites
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of cortisol
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of endogen steroids
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of testosterone
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of epitestosterone
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of androsterone
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of etiocholanolone
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of 5α-androstane-3α,17β-diol
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Plasma concentrations of 5β-androstane-3α,17β-diol
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient testosterone/epitestosterone in plasma
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient androsterone/testosterone in plasma
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient androsterone/Etio in plasma
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient 5aAdiol/5bAdiol in plasma
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Quotient 5aAdiol/ET in plasma
Time frame: Before drug administration and at 0.5h (hours), 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 120h, 192h post-administration
Hemoglobin concentration
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Hematocrit
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Mean corpuscular hemoglobin
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Mean corpuscular volume of erythrocytes
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Erythrocytes count
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Standard deviation of the range of distribution of erythrocytes
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Platelet count
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Reticulocyte count
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Fraction of immature reticulocytes
Time frame: At -72h (hours), -48h, -24h (before first administration), and at 0h, 1h, 3h, 6h after each dose (in multiple-dose treatments)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
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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.
Rosa Ventura Alemany, PharmD, PhD principal investigator
IMIM (Hospital del Mar Medical Research Institute)
Ana M Aldea Perona, MD, PhD principal investigator
IMIM (Hospital del Mar Medical Research Institute)
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 Methylprednisone, Deflazacort and Dexamethasone in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Ventura Alemany, PharmD, PhD (+34 933 160 471, rventura@imim.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine concentration of methylprednisone (time frame: 0-4h (hours), 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h, 72-96h, 96-120h post-administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021.