HealthyPhase 1NCT04811573

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

A Phase 1 study testing EU-sourced Otezla®, US-sourced Otezla® and Japan-sourced Otezla® in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: EU-sourced Otezla®, US-sourced Otezla® and Japan-sourced Otezla®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: 31 Mar 2021to 18 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 11Show fewer

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

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)

Conditions: Healthy
Being tested: EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EU-sourced Otezla®Drug
Also called Apremilast
Test product
US-sourced Otezla®Drug
Also called Apremilast
Reference product 1
Japan-sourced Otezla®Drug
Also called Apremilast
Reference product 2

Study groups in NCT04811573
Study group	Role	What they receive
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®
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. Receives: Drug: EU-sourced Otezla®; Drug: US-sourced Otezla®; Drug: Japan-sourced Otezla®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 202118 Aug 2021

First posted23 Mar 2021
Study start31 Mar 2021
Primary completion18 Aug 2021
Study completion18 Aug 2021

Why it stopped: due to company decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04811573
Sponsor's protocol ID: 1407-0041
Other IDs: 2019-005037-37, 2019
Status last verified: Aug 2022
First submitted: 22 Mar 2021
Last updated: 31 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04811573
Acronym / sponsor ID: 1407-0041
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: due to company decision
Enrolment: 20 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 31 Mar 2021 (actual)
Primary completion: 18 Aug 2021 (actual)
Study completion: 18 Aug 2021 (actual)
First posted: 23 Mar 2021 (actual)
Results: Posted 31 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 10
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

Arm	Type	Receives
EU-Otezla fasted(A)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ US-Otezla fed(D)/ EU-Otezla fed(C)	Experimental	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®Treatment sequence DCEAB is applied. The 5 treatments were separated by a washout period of at least 5 days.
Japan-Otezla fasted(E)/ US-Otezla fed(D)/ EU-Otezla fasted(A)/EU-Otezla fed(C)/ US-Otezla fasted(B)	Experimental	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®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	Drug: EU-sourced Otezla®, Drug: US-sourced Otezla®, Drug: Japan-sourced Otezla®Treatment sequence EADBC is applied. The 5 treatments were separated by a washout period of at least 5 days.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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:

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EU-sourced Otezla®Also: ApremilastTest product	Drug	EU-Otezla fasted(A)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ US-Otezla fed(D)/ EU-Otezla fed(C), EU-Otezla fasted(A)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ US-Otezla fed(D), EU-Otezla fed(C)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fasted(A), EU-Otezla fed(C)/US-Otezla fasted(B)/US-Otezla fasted(D)/EU-Otezla fasted(A)/ Japan-Otezla fasted(E), Japan-Otezla fasted(E)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ EU-Otezla fed(C), Japan-Otezla fasted(E)/ US-Otezla fed(D)/ EU-Otezla fasted(A)/EU-Otezla fed(C)/ US-Otezla fasted(B), US-Otezla fasted(B)/ EU-Otezla fasted(A)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fed(D), US-Otezla fasted(B)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ Japan-Otezla fasted(E), US-Otezla fed(D)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ EU-Otezla fasted(A), US-Otezla fed(D)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fasted(B)
US-sourced Otezla®Also: ApremilastReference product 1	Drug	EU-Otezla fasted(A)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ US-Otezla fed(D)/ EU-Otezla fed(C), EU-Otezla fasted(A)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ US-Otezla fed(D), EU-Otezla fed(C)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fasted(A), EU-Otezla fed(C)/US-Otezla fasted(B)/US-Otezla fasted(D)/EU-Otezla fasted(A)/ Japan-Otezla fasted(E), Japan-Otezla fasted(E)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ EU-Otezla fed(C), Japan-Otezla fasted(E)/ US-Otezla fed(D)/ EU-Otezla fasted(A)/EU-Otezla fed(C)/ US-Otezla fasted(B), US-Otezla fasted(B)/ EU-Otezla fasted(A)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fed(D), US-Otezla fasted(B)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ Japan-Otezla fasted(E), US-Otezla fed(D)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ EU-Otezla fasted(A), US-Otezla fed(D)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fasted(B)
Japan-sourced Otezla®Also: ApremilastReference product 2	Drug	EU-Otezla fasted(A)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ US-Otezla fed(D)/ EU-Otezla fed(C), EU-Otezla fasted(A)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ US-Otezla fed(D), EU-Otezla fed(C)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ Japan-Otezla fasted(E)/ EU-Otezla fasted(A), EU-Otezla fed(C)/US-Otezla fasted(B)/US-Otezla fasted(D)/EU-Otezla fasted(A)/ Japan-Otezla fasted(E), Japan-Otezla fasted(E)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ US-Otezla fasted(B)/ EU-Otezla fed(C), Japan-Otezla fasted(E)/ US-Otezla fed(D)/ EU-Otezla fasted(A)/EU-Otezla fed(C)/ US-Otezla fasted(B), US-Otezla fasted(B)/ EU-Otezla fasted(A)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fed(D), US-Otezla fasted(B)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fed(D)/ Japan-Otezla fasted(E), US-Otezla fed(D)/ EU-Otezla fed(C)/ Japan-Otezla fasted(E)/ US-Otezla fasted(B)/ EU-Otezla fasted(A), US-Otezla fed(D)/ Japan-Otezla fasted(E)/ EU-Otezla fed(C)/ EU-Otezla fasted(A)/ US-Otezla fasted(B)

Primary outcome

Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 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.
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.
Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 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.
The area under the concentration-time curve of apremilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Maximum Measured Concentration of Apremilast in Plasma (Cmax)
Time frame: 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.
The maximum measured concentration of apremilast in plasma (Cmax) is reported.

Results and safety

Results posted to the registry on 31 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EU-Otezla Fasted(A)/ Japan-Otezla Fasted(E)/ US-Otezla Fasted(B)/ US-Otezla Fed(D)/ EU-Otezla Fed(C)	2	2
US-Otezla Fasted(B)/ EU-Otezla Fasted(A)/ EU-Otezla Fed(C)/ Japan-Otezla Fasted(E)/ US-Otezla Fed(D)	2	2
EU-Otezla Fed(C)/US-Otezla Fasted(B)/US-Otezla Fed(D)/EU-Otezla Fasted(A)/ Japan-Otezla Fasted(E)	2	2
US-Otezla Fed(D)/ EU-Otezla Fed(C)/ Japan-Otezla Fasted(E)/ US-Otezla Fasted(B)/ EU-Otezla Fasted(A)	2	2
Japan-Otezla Fasted(E)/ US-Otezla Fed(D)/ EU-Otezla Fasted(A)/EU-Otezla Fed(C)/ US-Otezla Fasted(B)	2	2
EU-Otezla Fasted(A)/ US-Otezla Fasted(B)/ Japan-Otezla Fasted(E)/ EU-Otezla Fed(C)/ US-Otezla Fed(D)	2	2
US-Otezla Fasted(B)/ EU-Otezla Fed(C)/ EU-Otezla Fasted(A)/ US-Otezla Fed(D)/ Japan-Otezla Fasted(E)	2	2
EU-Otezla Fed(C)/ US-Otezla Fed(D)/ US-Otezla Fasted(B)/ Japan-Otezla Fasted(E)/ EU-Otezla Fasted(A)	2	2
US-Otezla Fed(D)/ Japan-Otezla Fasted(E)/ EU-Otezla Fed(C)/ EU-Otezla Fasted(A)/ US-Otezla Fasted(B)	2	2
Japan-Otezla Fasted(E)/ EU-Otezla Fasted(A)/ US-Otezla Fed(D)/ US-Otezla Fasted(B)/ EU-Otezla Fed(C)	2	2

Primary outcome: Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: hour * nanogram / milliliter (h*ng/mL)

Measure	EU-Otezla Fasted (A; Tfasted) n = 20	US-Otezla Fasted (B; R1fasted) n = 20	EU-Otezla Fed (C; Tfed) n = 20	US-Otezla Fed (D; R1fed) n = 20	Japan-Otezla Fasted (E; R2fasted) n = 20
Value	2390 (39.5)	2430 (35.5)	2580 (35.6)	2580 (39.6)	2350 (36.9)

Population analysed: 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.

Primary outcome: Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Measure	EU-Otezla Fasted (A; Tfasted) n = 20	US-Otezla Fasted (B; R1fasted) n = 20	EU-Otezla Fed (C; Tfed) n = 20	US-Otezla Fed (D; R1fed) n = 20	Japan-Otezla Fasted (E; R2fasted) n = 20
Value	2420 (39.3)	2460 (35.4)	2600 (35.6)	2600 (39.6)	2370 (36.9)

Primary outcome: Maximum Measured Concentration of Apremilast in Plasma (Cmax)

Measure	EU-Otezla Fasted (A; Tfasted) n = 20	US-Otezla Fasted (B; R1fasted) n = 20	EU-Otezla Fed (C; Tfed) n = 20	US-Otezla Fed (D; R1fed) n = 20	Japan-Otezla Fasted (E; R2fasted) n = 20
Value	298 (36.1)	301 (35.6)	303 (27.8)	271 (39.0)	299 (33.0)

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EU-Otezla Fasted (A; Tfasted)	0 of 20 (0%)	2 of 20 (10%)	0 of 20
US-Otezla Fasted (B; R1fasted)	0 of 20 (0%)	1 of 20 (5%)	0 of 20
EU-Otezla Fed (C; Tfed)	0 of 20 (0%)	3 of 20 (15%)	0 of 20
US-Otezla Fed (D; R1fed)	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Japan-Otezla Fasted (E; R2fasted)	0 of 20 (0%)	5 of 20 (25%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Related trials for Healthy

Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EU-sourced Otezla®, US-sourced Otezla® and Japan-sourced Otezla® in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of Apremilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.