HealthyPhase 1WADANCT03537326

Study to Detect Oral Administration of Budesonide in Women.

A Phase 1 study testing Budesonide in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.

Completed

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

Trial summary

This study aims at identifying analysis strategies to detect oral administration of Budesonide in women; in order for them to be used by the accredited laboratories of the Worl Anti-Doping Agency (WADA). Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Budesonide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteSpain
Study dates: 22 May 2018to 10 Sep 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
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female volunteers aged from 18 to 45 years.
Understand and accepting the procedures of the trial and sign an informed consent.
Have a history and physical exams that show that there is no organic or psychiatric problems.
The ECG, and the general blood and urine analyses done before the trial, have to be in the normal limits. Punctual or minor variations outside limits could be accepted if, according to the Main Investigator and regarding the state of science, they don't have clinical impact, can't present a risk for the subjects and don't interfere in the medication evaluation. These variations and their non-relevance will be specifically justified in writing.
The subjects must weigh between 50 and 75kg, with a BMI between 19 and 27 kg/m2.

Who cannot join

Don't fulfilling one or several inclusion criteria.
Have a medical history of allergy, idiosyncrasy, hypersensibility or adverse reactions to corticoids or the medication excipients. Have a medical history of serious adverse reaction to some medication.
Subjects with contraindication to treatments with the trial's medication (according to the respective data sheet).
Medical history or clinical evidence of gastrointestinal, hepatic or renal issue; or other types of issue that could suppose a deterioration of medication abortion, distribution, metabolism or excretion, or that could suggest gastrointestinal irritation by any medication.
Medical history or clinical evidence of issue that would be psychiatric, alcoholism, medication or drugs abuse, or usual consumption of psychoactive medication.
Participate in a clinical trial involving medication in the last 3 months before the beginning of the trial.

Show all 17Show fewer

Have done a blood donation during the last 3 months preceding of the study, if it's necessary to draw blood for the study.
Have suffered from an organic illness or major emergency during the 6 months preceding the trial.
Medical history or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematologic or neurologic disease; or other acute or chronic illness that, according to the Main Investigator or collaborators designated by him, could present a risk for the subjects or interfere in the study objectives. Especially osteoporosis, high blood pressure, Cushing syndrome, diabetes mellitus and viral infections such as herpes or varicella.
Having regularly taken medication during the month preceding the study, excepted vitamins, herbal medication or dietetics complementation that, according to the Main Investigator or collaborators designated by him, could present a risk for the subjects or interfere in the study objectives. The intake of a single-dose symptoms medication during the previous week will not be an exclusion criterion if it is considered as completely eliminated the day beginning the experimental session.
Smoke more than 20 cigarets per day during the last 3 months before the study.
Consume more than 20g of alcohol per day.
Consume more than 5 cafés, teas, cola drinks or other stimulating drinks or with xanthine per day in the 3 months preceding the start of the study.
Not being able to understand the nature of the study and procedures that it implies to follow.
Have a positive serology for B or C hepatitis or HIV.
Being pregnant or breastfeeding and don't use reliable means of contraception during the study.
Take hormonal contraceptives (oral, topic, injectable or vaginal).

Trial locations and contacts

1 site in 1 country.

Spain1 site

IMIM
Barcelona, 08003

Other trials in Spain

About this study

Read the detailed description

This clinical trial aims at studying the budesonide metabolism of women. The objective is to identify analysis strategies to detect oral administration of Budesonide in women. In order to use them in the accredited laboratories of the Worl Anti-Doping Agency (WADA).

This study will also help with defining the referential levels of this way of administration. Also, it will be used to test the safety and tolerability of the medication used.

For this, will be collected at precise times after the oral administration of the medication, the concentrations in urines of the metabolite o budesonide : the 6bêta-hydroxy-budesonide, of budesonide itself, of other metabolites. These concentrations will be compare to the ones in the basal samples of subject's urines.

Conditions: Healthy
Being tested: Budesonide
Keywords: doping

What participants receive

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

BudesonideDrug
Also called Entocord® modified release capsule, 3 mg single-dose
Patients will be given, on an empty stomach since a minimum of 10 hours, a single dose of 3 mg of Budesonide, in the form of Entocord® capsuls. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days.

Study groups in NCT03537326
Study group	Role	What they receive
Budesonide	Experimental	Healthy women, aged between 18 and 45 years old, with weigh between 50 and 75 kg and with IMC included between 19 and 27 kg/m². Patients will be given, on an empty stomach since 10 hours minimum, a single dose of 3 mg of Budesonide, in the form of Entocord ® tablets. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days. Receives: Drug: Budesonide

What is being measured

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

6β-hydroxy-budesonide urine concentration.
Many defined times after the oral administration of Entocord®, urine sample will be collected by the subjects and then analysed in laboratory to determine 6β-hydroxy-budesonide concentration.
Measured: 0-4 hr (hours) ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 h ; 72-96 hr after administration

Secondary outcomes (1)

Medication and other metabolites urine concentrations.
Many defined times after the oral administration of Entocord®, urine samples will be collected by the subjects and then analysed in laboratory to determine concentrations of Entocord® and other metabolites of budesonide.
Measured: 0-4 hr ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 hr ; 72-96 hr after administration

Timeline

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

22 May 201810 Sep 2018

First posted25 May 2018
Study start22 May 2018
Primary completion1 Jul 2018
Study completion10 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: Healthy women, aged between 18 and 45 years old, weighing between 50 and 75 kg and with BMI included between 19 and 27 kg/m².
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03537326
Sponsor's protocol ID: IMIMFTCL/DACORSIN/3
Other IDs: 2017-004839-37, 2017
Acronym: WADA
Status last verified: Sep 2018
First submitted: 15 May 2018
Last updated: 11 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bai TR. Glucocorticosteroid treatment of asthma. Can Fam Physician. 1995 Nov;41:1921-7.
PubMed 8563509
Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003.
PubMed 15634032
Deventer K, Delbeke FT. Validation of a screening method for corticosteroids in doping analysis by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2003;17(18):2107-14. doi: 10.1002/rcm.1157.
PubMed 12955741
Duclos M. [Use and abuse of anabolic steroids and glucocorticoids in sport]. Ann Endocrinol (Paris). 2007 Sep;68(4):308-14. doi: 10.1016/j.ando.2007.06.022. Epub 2007 Aug 8. No abstract available. French.
PubMed 17689473
Fluri K, Rivier L, Dienes-Nagy A, You C, Maitre A, Schweizer C, Saugy M, Mangin P. Method for confirmation of synthetic corticosteroids in doping urine samples by liquid chromatography-electrospray ionisation mass spectrometry. J Chromatogr A. 2001 Aug 10;926(1):87-95. doi: 10.1016/s0021-9673(01)01065-2.
PubMed 11554422
Ho EN, Leung DK, Wan TS, Yu NH. Comprehensive screening of anabolic steroids, corticosteroids, and acidic drugs in horse urine by solid-phase extraction and liquid chromatography-mass spectrometry. J Chromatogr A. 2006 Jul 7;1120(1-2):38-53. doi: 10.1016/j.chroma.2006.03.089. Epub 2006 May 2.
PubMed 16631183
Matabosch X, Pozo OJ, Perez-Mana C, Farre M, Marcos J, Segura J, Ventura R. Discrimination of prohibited oral use from authorized inhaled treatment of budesonide in sports. Ther Drug Monit. 2013 Feb;35(1):118-28. doi: 10.1097/FTD.0b013e3182787b20.
PubMed 23318282
Matabosch X, Pozo OJ, Perez-Mana C, Farre M, Marcos J, Segura J, Ventura R. Identification of budesonide metabolites in human urine after oral administration. Anal Bioanal Chem. 2012 Aug;404(2):325-40. doi: 10.1007/s00216-012-6037-0. Epub 2012 May 10.
PubMed 22573060
Spyridaki MH, Kiousi P, Vonaparti A, Valavani P, Zonaras V, Zahariou M, Sianos E, Tsoupras G, Georgakopoulos C. Doping control analysis in human urine by liquid chromatography-electrospray ionization ion trap mass spectrometry for the Olympic Games Athens 2004: determination of corticosteroids and quantification of ephedrines, salbutamol and morphine. Anal Chim Acta. 2006 Jul 28;573-574:242-9. doi: 10.1016/j.aca.2006.04.042. Epub 2006 Apr 27.
PubMed 17723530
Touber ME, van Engelen MC, Georgakopoulus C, van Rhijn JA, Nielen MW. Multi-detection of corticosteroids in sports doping and veterinary control using high-resolution liquid chromatography/time-of-flight mass spectrometry. Anal Chim Acta. 2007 Mar 14;586(1-2):137-46. doi: 10.1016/j.aca.2006.09.058. Epub 2006 Oct 5.
PubMed 17386705
Andersen JH, Hansen LG, Pedersen M. Optimization of solid phase extraction clean up and validation of quantitative determination of corticosteroids in urine by liquid chromatography-tandem mass spectrometry. Anal Chim Acta. 2008 Jun 9;617(1-2):216-24. doi: 10.1016/j.aca.2008.02.070. Epub 2008 Mar 27.
PubMed 18486661

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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Detect Oral Administration of Budesonide in Women.
ClinicalTrials.gov ID: NCT03537326
Acronym / sponsor ID: WADA / IMIMFTCL/DACORSIN/3
Conditions: Healthy
Keywords: doping
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: Parc de Salut MarUniversity, hospital or other
Study start: 22 May 2018 (actual)
Primary completion: 1 Jul 2018 (actual)
Study completion: 10 Sep 2018 (actual)
First posted: 25 May 2018 (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.

Detailed description

This study will also help with defining the referential levels of this way of administration. Also, it will be used to test the safety and tolerability of the medication used.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Healthy women, aged between 18 and 45 years old, weighing between 50 and 75 kg and with BMI included between 19 and 27 kg/m².

Arm	Type	Receives
Budesonide	Experimental	Drug: BudesonideHealthy women, aged between 18 and 45 years old, with weigh between 50 and 75 kg and with IMC included between 19 and 27 kg/m². Patients will be given, on an empty stomach since 10 hours minimum, a single dose of 3 mg of Budesonide, in the form of Entocord ® tablets. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days.

Who may qualify

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

Key inclusion criteria (5 listed)

Female volunteers aged from 18 to 45 years.
Understand and accepting the procedures of the trial and sign an informed consent.
Have a history and physical exams that show that there is no organic or psychiatric problems.
The ECG, and the general blood and urine analyses done before the trial, have to be in the normal limits. Punctual or minor variations outside limits could be accepted if, according to the Main Investigator and regarding the state of science, they don't have clinical impact, can't present a risk for the subjects and don't interfere in the medication evaluation. These variations and their non-relevance will be specifically justified in writing.
The subjects must weigh between 50 and 75kg, with a BMI between 19 and 27 kg/m2.

Key exclusion criteria (17 listed)

Don't fulfilling one or several inclusion criteria.
Have a medical history of allergy, idiosyncrasy, hypersensibility or adverse reactions to corticoids or the medication excipients. Have a medical history of serious adverse reaction to some medication.
Subjects with contraindication to treatments with the trial's medication (according to the respective data sheet).
Medical history or clinical evidence of gastrointestinal, hepatic or renal issue; or other types of issue that could suppose a deterioration of medication abortion, distribution, metabolism or excretion, or that could suggest gastrointestinal irritation by any medication.
Medical history or clinical evidence of issue that would be psychiatric, alcoholism, medication or drugs abuse, or usual consumption of psychoactive medication.

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
BudesonideAlso: Entocord® modified release capsule, 3 mg single-dosePatients will be given, on an empty stomach since a minimum of 10 hours, a single dose of 3 mg of Budesonide, in the form of Entocord® capsuls. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days.	Drug	Budesonide

Primary outcome

6β-hydroxy-budesonide urine concentration.
Time frame: 0-4 hr (hours) ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 h ; 72-96 hr after administration
Many defined times after the oral administration of Entocord®, urine sample will be collected by the subjects and then analysed in laboratory to determine 6β-hydroxy-budesonide concentration.

1 secondary outcome

Medication and other metabolites urine concentrations.
Time frame: 0-4 hr ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 hr ; 72-96 hr after administration

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 11 Sep 2018.
Background: PubMed 8563509Bai TR. Glucocorticosteroid treatment of asthma. Can Fam Physician. 1995 Nov;41:1921-7.
Background: PubMed 15634032Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003.
Background: PubMed 12955741Deventer K, Delbeke FT. Validation of a screening method for corticosteroids in doping analysis by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2003;17(18):2107-14. doi: 10.1002/rcm.1157.
Background: PubMed 17689473Duclos M. [Use and abuse of anabolic steroids and glucocorticoids in sport]. Ann Endocrinol (Paris). 2007 Sep;68(4):308-14. doi: 10.1016/j.ando.2007.06.022. Epub 2007 Aug 8. No abstract available. French.
Background: PubMed 11554422Fluri K, Rivier L, Dienes-Nagy A, You C, Maitre A, Schweizer C, Saugy M, Mangin P. Method for confirmation of synthetic corticosteroids in doping urine samples by liquid chromatography-electrospray ionisation mass spectrometry. J Chromatogr A. 2001 Aug 10;926(1):87-95. doi: 10.1016/s0021-9673(01)01065-2.
Background: PubMed 16631183Ho EN, Leung DK, Wan TS, Yu NH. Comprehensive screening of anabolic steroids, corticosteroids, and acidic drugs in horse urine by solid-phase extraction and liquid chromatography-mass spectrometry. J Chromatogr A. 2006 Jul 7;1120(1-2):38-53. doi: 10.1016/j.chroma.2006.03.089. Epub 2006 May 2.
Background: PubMed 23318282Matabosch X, Pozo OJ, Perez-Mana C, Farre M, Marcos J, Segura J, Ventura R. Discrimination of prohibited oral use from authorized inhaled treatment of budesonide in sports. Ther Drug Monit. 2013 Feb;35(1):118-28. doi: 10.1097/FTD.0b013e3182787b20.
Background: PubMed 22573060Matabosch X, Pozo OJ, Perez-Mana C, Farre M, Marcos J, Segura J, Ventura R. Identification of budesonide metabolites in human urine after oral administration. Anal Bioanal Chem. 2012 Aug;404(2):325-40. doi: 10.1007/s00216-012-6037-0. Epub 2012 May 10.
Background: PubMed 17723530Spyridaki MH, Kiousi P, Vonaparti A, Valavani P, Zonaras V, Zahariou M, Sianos E, Tsoupras G, Georgakopoulos C. Doping control analysis in human urine by liquid chromatography-electrospray ionization ion trap mass spectrometry for the Olympic Games Athens 2004: determination of corticosteroids and quantification of ephedrines, salbutamol and morphine. Anal Chim Acta. 2006 Jul 28;573-574:242-9. doi: 10.1016/j.aca.2006.04.042. Epub 2006 Apr 27.
Background: PubMed 17386705Touber ME, van Engelen MC, Georgakopoulus C, van Rhijn JA, Nielen MW. Multi-detection of corticosteroids in sports doping and veterinary control using high-resolution liquid chromatography/time-of-flight mass spectrometry. Anal Chim Acta. 2007 Mar 14;586(1-2):137-46. doi: 10.1016/j.aca.2006.09.058. Epub 2006 Oct 5.
Results publication: PubMed 18486661Andersen JH, Hansen LG, Pedersen M. Optimization of solid phase extraction clean up and validation of quantitative determination of corticosteroids in urine by liquid chromatography-tandem mass spectrometry. Anal Chim Acta. 2008 Jun 9;617(1-2):216-24. doi: 10.1016/j.aca.2008.02.070. Epub 2008 Mar 27.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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, Pharmacéutic principal investigator

Laboratorio Antidopaje de Catalunya.

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 Budesonide in people with Healthy, 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 17 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 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 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?

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?

6β-hydroxy-budesonide urine concentration. (time frame: 0-4 hr (hours) ; 4-8 hr ; 8-12 hr ; 12-24 hr ; 24-36 hr ; 36-48 hr ; 48-72 h ; 72-96 hr after administration). 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 NCT03537326, which also lists 11 linked publications.

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 2018.