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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-005037-37 | EudraCT Number |
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due to company decision
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The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis as well as other T helper 17 cells (Th17)-mediated diseases) regardless of whether only the EU-sourced Otezla® or EU and US-sourced Otezla®/Japan-sourced Otezla® have been used as an active comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EU-Otezla fasted(A)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ US-Otezla fed(D)/ EU-Otezla fed(C) | Experimental | Treatment sequence AEBDC is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| US-Otezla fasted(B)/ EU-Otezla fasted(A)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fed(D) | Experimental | Treatment sequence BACED is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| EU-Otezla fed(C)/US-Otezla fasted(B)/US-Otezla fasted(D)/EU-Otezla fasted(A)/ Japan-Otezla fasted(E) | Experimental | Treatment sequence CBDAE is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| US-Otezla fed(D)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ EU-Otezla fasted(A) | Experimental | Treatment sequence DCEAB is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EU-sourced Otezla® | Drug | Test product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | The area under the concentration-time curve of apremilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | 1 hour (h) before and 30 minutes (min), 1h, 1h30min, 2h, 2h30min, 3h, 3h30min, 4h, 5h, 6h, 8h, 11h, 15h, 24h, 36h, 48h after study drug administration. |
| Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | The area under the concentration-time curve of apremilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | 1 hour (h) before and 30 minutes (min), 1h, 1h30min, 2h, 2h30min, 3h, 3h30min, 4h, 5h, 6h, 8h, 11h, 15h, 24h, 36h, 48h after study drug administration. |
| Maximum Measured Concentration of Apremilast in Plasma (Cmax) | The maximum measured concentration of apremilast in plasma (Cmax) is reported. | 1 hour (h) before and 30 minutes (min), 1h, 1h30min, 2h, 2h30min, 3h, 3h30min, 4h, 5h, 6h, 8h, 11h, 15h, 24h, 36h, 48h after study drug administration. |
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Inclusion Criteria:
Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Male subjects, or female subjects who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This open-label, randomised, single-dose, five-period, ten-sequence crossover study was to compare the test treatment (EU-sourced Otezla) to the reference treatments US-sourced Otezla and Japan-sourced Otezla) under fasting and fed conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | EU-Otezla Fasted(A)/ Japan-Otezla Fasted(E)/ US-Otezla Fasted(B)/ US-Otezla Fed(D)/ EU-Otezla Fed(C) | Treatment sequence AEBDC was applied: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG001 | US-Otezla Fasted(B)/ EU-Otezla Fasted(A)/ EU-Otezla Fed(C)/ Japan-Otezla Fasted(E)/ US-Otezla Fed(D) | Treatment sequence BACED was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG002 | EU-Otezla Fed(C)/US-Otezla Fasted(B)/US-Otezla Fed(D)/EU-Otezla Fasted(A)/ Japan-Otezla Fasted(E) | Treatment sequence CBDAE was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG003 | US-Otezla Fed(D)/ EU-Otezla Fed(C)/ Japan-Otezla Fasted(E)/ US-Otezla Fasted(B)/ EU-Otezla Fasted(A) | Treatment sequence DCEAB was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG004 | Japan-Otezla Fasted(E)/ US-Otezla Fed(D)/ EU-Otezla Fasted(A)/EU-Otezla Fed(C)/ US-Otezla Fasted(B) | Treatment sequence EDACB was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG005 | EU-Otezla Fasted(A)/ US-Otezla Fasted(B)/ Japan-Otezla Fasted(E)/ EU-Otezla Fed(C)/ US-Otezla Fed(D) | Treatment sequence ABECD was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG006 | US-Otezla Fasted(B)/ EU-Otezla Fed(C)/ EU-Otezla Fasted(A)/ US-Otezla Fed(D)/ Japan-Otezla Fasted(E) | Treatment sequence BCADE was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG007 | EU-Otezla Fed(C)/ US-Otezla Fed(D)/ US-Otezla Fasted(B)/ Japan-Otezla Fasted(E)/ EU-Otezla Fasted(A) | Treatment sequence CDBEA was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG008 | US-Otezla Fed(D)/ Japan-Otezla Fasted(E)/ EU-Otezla Fed(C)/ EU-Otezla Fasted(A)/ US-Otezla Fasted(B) | Treatment sequence DECAB was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| FG009 | Japan-Otezla Fasted(E)/ EU-Otezla Fasted(A)/ US-Otezla Fed(D)/ US-Otezla Fasted(B)/ EU-Otezla Fed(C) | Treatment sequence EADBC was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EU-Otezla Fasted(A)/ Japan-Otezla Fasted(E)/ US-Otezla Fasted(B)/ US-Otezla Fed(D)/ EU-Otezla Fed(C) | Treatment sequence AEBDC was applied: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | The area under the concentration-time curve of apremilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | Pharmacokinetic (PK) set: This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanogram / milliliter (h*ng/mL) | 1 hour (h) before and 30 minutes (min), 1h, 1h30min, 2h, 2h30min, 3h, 3h30min, 4h, 5h, 6h, 8h, 11h, 15h, 24h, 36h, 48h after study drug administration. |
|
For serious and non-serious adverse events: From drug administration until end of residual effect period of 4 days, up to 5 days for each treatment group. For all-cause mortality: From drug administration until end of follow-up period, up to 11 days for each treatment group.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EU-Otezla Fasted (A; Tfasted) | One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
This trial was prematurely discontinued due to sponsor decision. The planned recruitment amount was not reached. The planned statistical analyses of the pharmacokinetic parameters were not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 18002430127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2020 | Aug 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2021 | Aug 11, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
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Five-period, ten-sequence crossover trial.
Periods:
(A): EU-sourced Otezla - fasted condition (B): US-sourced Otezla - fasted condition (C): EU-sourced Otezla - fed condition (C): US-sourced Otezla - fed condition (E): Japan-sourced Otezla - fasted condition
Sequences: see Arms
Not provided
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| Japan-Otezla fasted(E)/ US-Otezla fed(D)/ EU-Otezla fasted(A)/EU-Otezla fed(C)/ US-Otezla fasted(B) | Experimental | Treatment sequence EDACB is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| EU-Otezla fasted(A)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ US-Otezla fed(D) | Experimental | Treatment sequence ABECD is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| US-Otezla fasted(B)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ Japan-Otezla fasted(E) | Experimental | Treatment sequence BCADE is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| EU-Otezla fed(C)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fasted(A) | Experimental | Treatment sequence CDBEA is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| US-Otezla fed(D)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fasted(B) | Experimental | Treatment sequence DECAB is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
| Japan-Otezla fasted(E)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ EU-Otezla fed(C) | Experimental | Treatment sequence EADBC is applied. The 5 treatments were separated by a washout period of at least 5 days. |
|
|
| US-sourced Otezla® | Drug | Reference product 1 |
|
|
| Japan-sourced Otezla® | Drug | Reference product 2 |
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| BG001 | US-Otezla Fasted(B)/ EU-Otezla Fasted(A)/ EU-Otezla Fed(C)/ Japan-Otezla Fasted(E)/ US-Otezla Fed(D) | Treatment sequence BACED was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG002 | EU-Otezla Fed(C)/US-Otezla Fasted(B)/US-Otezla Fed(D)/EU-Otezla Fasted(A)/ Japan-Otezla Fasted(E) | Treatment sequence CBDAE was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG003 | US-Otezla Fed(D)/ EU-Otezla Fed(C)/ Japan-Otezla Fasted(E)/ US-Otezla Fasted(B)/ EU-Otezla Fasted(A) | Treatment sequence DCEAB was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG004 | Japan-Otezla Fasted(E)/ US-Otezla Fed(D)/ EU-Otezla Fasted(A)/EU-Otezla Fed(C)/ US-Otezla Fasted(B) | Treatment sequence EDACB was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG005 | EU-Otezla Fasted(A)/ US-Otezla Fasted(B)/ Japan-Otezla Fasted(E)/ EU-Otezla Fed(C)/ US-Otezla Fed(D) | Treatment sequence ABECD was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG006 | US-Otezla Fasted(B)/ EU-Otezla Fed(C)/ EU-Otezla Fasted(A)/ US-Otezla Fed(D)/ Japan-Otezla Fasted(E) | Treatment sequence BCADE was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG007 | EU-Otezla Fed(C)/ US-Otezla Fed(D)/ US-Otezla Fasted(B)/ Japan-Otezla Fasted(E)/ EU-Otezla Fasted(A) | Treatment sequence CDBEA was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG008 | US-Otezla Fed(D)/ Japan-Otezla Fasted(E)/ EU-Otezla Fed(C)/ EU-Otezla Fasted(A)/ US-Otezla Fasted(B) | Treatment sequence DECAB was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG009 | Japan-Otezla Fasted(E)/ EU-Otezla Fasted(A)/ US-Otezla Fed(D)/ US-Otezla Fasted(B)/ EU-Otezla Fed(C) | Treatment sequence EADBC was applied with the following treatments: EU-Otezla fasted(A): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). US-Otezla fasted(B): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). EU-Otezla fed(C): One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). US-Otezla fed(D): One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). Japan-Otezla fasted(E): One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). The 5 treatments were separated by a washout period of at least 5 days. |
| BG010 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | US-Otezla Fasted (B; R1fasted) | One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). |
| OG002 | EU-Otezla Fed (C; Tfed) | One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). |
| OG003 | US-Otezla Fed (D; R1fed) | One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). |
| OG004 | Japan-Otezla Fasted (E; R2fasted) | One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). |
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| Primary | Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | The area under the concentration-time curve of apremilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | Pharmacokinetic (PK) set: This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanogram / milliliter (h*ng/mL) | 1 hour (h) before and 30 minutes (min), 1h, 1h30min, 2h, 2h30min, 3h, 3h30min, 4h, 5h, 6h, 8h, 11h, 15h, 24h, 36h, 48h after study drug administration. |
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| Primary | Maximum Measured Concentration of Apremilast in Plasma (Cmax) | The maximum measured concentration of apremilast in plasma (Cmax) is reported. | Pharmacokinetic (PK) set: This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram / milliliter (ng/mL) | 1 hour (h) before and 30 minutes (min), 1h, 1h30min, 2h, 2h30min, 3h, 3h30min, 4h, 5h, 6h, 8h, 11h, 15h, 24h, 36h, 48h after study drug administration. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | US-Otezla Fasted (B; R1fasted) | One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). | 0 | 20 | 0 | 20 | 1 | 20 |
| EG002 | EU-Otezla Fed (C; Tfed) | One EU-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). | 0 | 20 | 0 | 20 | 3 | 20 |
| EG003 | US-Otezla Fed (D; R1fed) | One US-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fed state (after a high-fat, high-calorie meal). | 0 | 20 | 0 | 20 | 5 | 20 |
| EG004 | Japan-Otezla Fasted (E; R2fasted) | One Japan-sourced Otezla® film-coated tablet of 30 milligrams (mg) apremilast was administered orally with 240 milliliter (mL) water as a single dose in the fasted state (after an overnight fasting period of at least 10 hours (h)). | 0 | 20 | 0 | 20 | 5 | 20 |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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Not provided
Not provided
Not provided