A Phase 1 interventional study of Beclomethasone dipropionate in Healthy Adult Male Volunteers, sponsored by SOFAR S.p.A.. Completed at 1 site in Italy. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by SOFAR S.p.A. · Phase 1, Interventional, and Other
Single-centre, randomized, double-blind, two-period, two-sequence, cross-over 7-day study.
This study is the first safety/tolerability evaluation of a product -suppository formulation containing 6 mg BDP (once daily dosing), a second-generation oral or rectal corticosteroids with high topical anti-inflammatory efficacy in the gut and minimal systemic bioavailability (BA).
BDP is marketed in different pharmaceutical formulations, including 3 mg suppositories, and approved for ulcerative proctosigmoiditis in the first attack or exacerbation phase at the dosage of 3 mg twice a day. For these reasons, a 6 mg suppository (Test - "T" product) is a scale-up of the 3 mg formulation (Reference - "R" product).
For locally-applied-locally acting drug products that result in quantifiable systemic availability due to absorption from the administration site, relative systemic BA is informative for safety, but also with respect to efficacy. Therefore, safety/tolerability of T is evaluated through a comparison to R.
Primary objective is the evaluation of systemic safety of T, based on valid surrogate outcomes - systemic BA (relative BA) at the start of treatment (first 24 hours) and after 7 days of continuous treatment; effects on the hypothalamo-pituitary-adrenal axis (HPA) assessed based on 24-hour cortisol profile after 7 days of continuous treatment. This includes identification of subjects with cortisol levels \<10 μg/dL at the last sampling point in the 24-hour cortisol profile (08:00 a.m. on Day 8). In such cases, identified subjects will undergo ACTH stimulation test in the morning of Day 9.
Secondary objective is the evaluation of safety/tolerability based on clinical and laboratory adverse events.
SOFAR S.p.A. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 3 mg BDP suppositories (R product) delivered twice daily for 7 days * Washout period (at least 7-day and preferably no more than 9 days) * 6 mg BDP suppositories (T product) delivered once daily in the morning for 7 days. Matching placebo suppository will be applied rectally once daily in the evening, on same days as the T product.
Drug: Beclomethasone dipropionate
* 6 mg BDP suppositories (T product) delivered once daily in the morning for 7 days. Matching placebo suppository will be applied rectally once daily in the evening, on same days as the T product. * Washout period (at least 7-day and preferably no more than 9 days) * 3 mg BDP suppositories (R product) delivered twice daily for 7 days
Drug: Beclomethasone dipropionate
BDP 3 mg bid (R product) BDP 6 mg qd (T product)
Also known as: Beclomethasone 17,21-dipropionate, BDP
Pharmacokinetics - Cmax, morning;
Peak exposure after the morning dose (Cmax, morning)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - Cmax, evening;
Peak exposure after the evening dose (Cmax, evening)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - AUC0-24
• Total exposure over 24 hours (AUC0-24)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - AUC0-12
• Total exposure during dosing interval - morning (AUC0-12)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - AUC12-24
• Total exposure during dosing interval - evening (AUC12-24)
Time frame: Day 1 and Day 7 of each Period
HPA-axis: 24-hour plasma cortisol - AUC0-24, cortisol
Area under the cortisol level-time curve over 24 hours (AUC0-24, cortisol). AUC will be determined for each subject/treatment at baseline and at Day 7 by the linear trapezoidal rule and ln-transformed. Ln(AUCs) will be used to determine intra-subject difference Day 7 - baseline that will be subject to analysis.
Time frame: Baseline and Day 7 of each Period
HPA-axis: 24-hour plasma cortisol - AUC0-12, cortisol
Area under the cortisol level-time curve over 12 hours after the morning dose (AUC0-12, cortisol). As above.
Time frame: Baseline and Day 7 of each Period
HPA-axis: 24-hour plasma cortisol - AUC12-24, cortisol
Area under the cortisol level-time curve over 12 hours after the evening dose (AUC12-24, cortisol). As above.
Time frame: Baseline and Day 7 of each Period
HPA-axis: 24-hour plasma cortisol - pAUC2-8, cortisol
Partial area under the cortisol level-time curve "covering" 3rd, 4th, 5th, 6th, 7th and 8th hour post morning dose (i.e., between 10:00 and 16:00 hours, that is, between sampling times at 2 and 8 hours post-dose) - a time period during which normal cortisol levels are still relatively high and the strongest suppression after morning dose could be expected (pAUC2-8, cortisol). As above.
Time frame: Baseline and Day 7 of each Period
Pharmacokinetics - trough concentrations
Trough concentrations for R (C12) and T (C24) dosing on Day 1 and Day 7 as well as morning pre-dose (C0)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - Cmax morning/AUC0-12 ratio
Ratio of the peak exposure after the morning dose to exposure over the subsequent 12 hours (illustrates absorption rate) (Cmax,morning/AUC0-12)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - Tmax, morning
Time to peak exposure after the morning dose (Tmax,morning)
Time frame: Day 1 and Day 7 of each Period
Pharmacokinetics - Percent fluctuation (%PTF12)
Day 7 - percent fluctuation over 12 hours after morning dose (%PTF12)
Time frame: Day 7 of each Period
Pharmacokinetics - Percent fluctuation (%PTF24)
Day 7 - percent fluctuation over 24 hours (%PTF24)
Time frame: Day 7 of each Period
Pharmacokinetics - Accumulation ratio
Accumulation ratio (Cmax,morning Day 7/Day 1; AUC0-24 Day 7/Day 1). Accumulation ratio will be estimated based on two outcomes: peak exposure after the morning dose (Cmax, morning) and total exposure over 24 hours (AUC0-24).
Time frame: Day 1 and Day 7 of each Period
HPA axis - Number (proportion) of subjects with cortisol <10 μg/dL
ACTH stimulation test results on the morning of Day 9 (first post-dosing day) dichotomized as "normal" or "abnormal"
Time frame: Day 8 and 9 of each Period
HPA axis - Number/proportion of subjects with abnormal ACTH stimulation test.
Number (proportion) of subjects with cortisol levels \<10 μg/dL at 08:00 a.m. on Day 8 and number (proportion) of subjects with abnormal ACTH stimulation test results in the morning of Day 9 (should any subject be submitted).
Time frame: Day 8 and 9 of each Period
HPA axis - 24-hour cortisol profile
24-hour cortisol profile: time-point-by-time-point differences Day 7 vs. baseline
Time frame: Baseline and Day 7 of each Period
Safety - Adverse Events
Adverse events reporting
Time frame: From screening to follow up (approximately 59 days)
Safety - Laboratory values
Incidence of abnormal laboratory test results (Urinalysis, biochemical and haematological tests performed)
Time frame: At screening, before each period and at follow-up (+21 days after the end of Period 2)
Plan to share: Yes
Supporting information: Study protocol, Informed consent form, Clinical study report
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beclomethasone
SOFAR S.p.A.