A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-08-18

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EU-Otezla fasted(A)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ US-Otezla fed(D)/ EU-Otezla fed(C)

Treatment sequence AEBDC is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

US-Otezla fasted(B)/ EU-Otezla fasted(A)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fed(D)

Treatment sequence BACED is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

EU-Otezla fed(C)/US-Otezla fasted(B)/US-Otezla fasted(D)/EU-Otezla fasted(A)/ Japan-Otezla fasted(E)

Treatment sequence CBDAE is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

US-Otezla fed(D)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ EU-Otezla fasted(A)

Treatment sequence DCEAB is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

Japan-Otezla fasted(E)/ US-Otezla fed(D)/ EU-Otezla fasted(A)/EU-Otezla fed(C)/ US-Otezla fasted(B)

Treatment sequence EDACB is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

EU-Otezla fasted(A)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ US-Otezla fed(D)

Treatment sequence ABECD is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

US-Otezla fasted(B)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ Japan-Otezla fasted(E)

Treatment sequence BCADE is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

EU-Otezla fed(C)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fasted(A)

Treatment sequence CDBEA is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

US-Otezla fed(D)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fasted(B)

Treatment sequence DECAB is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

Japan-Otezla fasted(E)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ EU-Otezla fed(C)

Treatment sequence EADBC is applied. The 5 treatments were separated by a washout period of at least 5 days.

Group Type EXPERIMENTAL

EU-sourced Otezla®

Intervention Type DRUG

Test product

US-sourced Otezla®

Intervention Type DRUG

Reference product 1

Japan-sourced Otezla®

Intervention Type DRUG

Reference product 2

Interventions

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EU-sourced Otezla®

Test product

Intervention Type DRUG

US-sourced Otezla®

Reference product 1

Intervention Type DRUG

Japan-sourced Otezla®

Reference product 2

Intervention Type DRUG

Other Intervention Names

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Apremilast Apremilast Apremilast

Eligibility Criteria

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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:

* Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
* Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
* Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
* A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
* Surgically sterilised (including hysterectomy or bilateral occlusion)
* Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes