A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
Condition: Healthy
Intervention: EU-sourced Otezla®; US-sourced Otezla®; Japan-sourced Otezla®
Intervention description: Test product; Reference product 1; Reference product 2
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts Further
             exclusion criteria apply.