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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04811573
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 5
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: EU-sourced Otezla® (T); Drug: US-sourced Otezla® (R1); Drug: Japan-sourced Otezla® (R2)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bioequivalence of Three Different Tablet Formulations of 30 mg of Apremilast (EU-sourced Otezla® vs. US-sourced Otezla® vs. Japan-sourced Otezla®) Administered in Healthy Male and Female Subjects in the Fasted State as Well as (for EU-sourced Otezla® vs. US-sourced Otezla®) in the Fed State (an Open-label, Randomised, Single-dose, Five-period, Ten-sequence Crossover Study)
• Actual Study Start Date: Mar 31, 2021
• Actual Primary Completion Date: Aug 18, 2021
• Actual Study Completion Date: Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tfasted T: Test Treatment fasted: under fasted conditions	Drug: EU-sourced Otezla® (T); Test Treatment (T)
Experimental: R1fasted R1: Reference 1 Treatment fasted: under fasted conditions	Drug: US-sourced Otezla® (R1); Reference Treatment (R1)
Experimental: R2fasted R2: Reference 2 Treatment fasted: under fasted conditions	Drug: Japan-sourced Otezla® (R2); Reference Treatment (R2)
Experimental: Tfed T: Test Treatment fed: under fed conditions	Drug: EU-sourced Otezla® (T); Test Treatment (T)
Experimental: R1fed R1: Reference 1 Treatment fed: under fed conditions	Drug: US-sourced Otezla® (R1); Reference Treatment (R1)

Outcome Measures

Primary Outcome Measures

1. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [up to 48 hours]

2. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 48 hours]

3. Cmax (maximum measured concentration of the analyte in plasma) [up to 48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humanpharmakologisches Zentrum Biberach	Biberach		Germany	88397

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04811573
• Other Study ID Numbers: 1407-0041; 2019-005037-37
• First Posted: Mar 23, 2021
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Thalidomide; Apremilast

Study Results

No Results Posted as of Sep 5, 2021