Explorative Study of the Safety/Tolerability of Beclomethasone Dipropionate Suppositories: Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers
Sponsor study identifier
interventional
28
1 country
1
Study Start
October 22, 2021
Actual (reported)Primary Completion
April 28, 2022
Actual (reported)Study Completion
April 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 28, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2021
Actual (reported)May 5, 2021
Actual (reported)October 22, 2021
Actual (reported)April 28, 2022
Actual (reported)April 28, 2022
Actual (reported)Pharmacokinetics - Cmax, morning;
Peak exposure after the morning dose (Cmax, morning)
Day 1 and Day 7 of each Period
Pharmacokinetics - Cmax, evening;
Peak exposure after the evening dose (Cmax, evening)
Day 1 and Day 7 of each Period
Pharmacokinetics - AUC0-24
• Total exposure over 24 hours (AUC0-24)
Day 1 and Day 7 of each Period
Pharmacokinetics - AUC0-12
• Total exposure during dosing interval - morning (AUC0-12)
Day 1 and Day 7 of each Period
Pharmacokinetics - AUC12-24
• Total exposure during dosing interval - evening (AUC12-24)
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.
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.
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.
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.
Baseline and Day 7 of each Period
Pharmacokinetics - trough concentrations
Day 1 and Day 7 of each Period
Pharmacokinetics - Cmax morning/AUC0-12 ratio
Day 1 and Day 7 of each Period
Pharmacokinetics - Tmax, morning
Day 1 and Day 7 of each Period
Pharmacokinetics - Percent fluctuation (%PTF12)
Day 7 of each Period
Pharmacokinetics - Percent fluctuation (%PTF24)
Day 7 of each Period
Safety - Adverse Events
From screening to follow up (approximately 59 days)
Safety - Laboratory values
At screening, before each period and at follow-up (+21 days after the end of Period 2)
* 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.
* 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
BDP 3 mg bid (R product) BDP 6 mg qd (T product)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centro Ricerche Cliniche AOU Integrata di Verona - Policlinico Universitario G.B. Rossi
Verona, 37134, Italy
28 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2021
First Posted
May 5, 2021
Study Start
October 22, 2021
Actual (reported)Study to Evaluate the Mass Babance and Biotransformation of [14C]SHR6390 in Healthy Adult Male Volunteers
Contact the study team to confirm eligibility.
Primary Completion
April 28, 2022
Actual (reported)Study Completion
April 28, 2022
Actual (reported)Last Updated
May 4, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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