HealthyPhase 1NCT04899674

A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood

A Phase 1 study testing Elontril and BI 1358894 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of bupropion when given alone (Reference) compared with co-administration (Test) with BI 1358894 in healthy volunteers. 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?: Elontril and BI 1358894
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: 30 Jun 2021to 2 Sep 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 from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Sexually abstinent

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Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, intrauterine device
A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
Surgically sterilised (including hysterectomy)
Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (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 safety laboratory, 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 beats per minute (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

CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167

Other trials in Germany

About this study

Official title: An Open-label, Two-period Fixed Sequence Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of Bupropion in Healthy Volunteers

Conditions: Healthy
Being tested: Elontril, BI 1358894

What participants receive

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

ElontrilDrug
Also called Bupropion hydrochloride
Tablet
BI 1358894Drug
Film coated tablet

Study groups in NCT04899674
Study group	Role	What they receive
bupropion alone (Reference (R)) then BI 1358894 + bupropion (Test (T))	Experimental	Not described Receives: Drug: Elontril; Drug: BI 1358894

What is being measured

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

Area Under the Concentration-time Curve of Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Time Frame: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))".
Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Measured: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).
Maximum Measured Concentration of Bupropion in Plasma (Cmax)
Maximum measured concentration of bupropion in plasma (Cmax) is presented.
Timeframe: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))".
Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Measured: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).

Secondary outcomes (1)

Area Under the Concentration-time Curve of Bupropion in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
Time Frame: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))".
Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Measured: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).

Timeline

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

30 Jun 20212 Sep 2021

First posted24 May 2021
Study start30 Jun 2021
Primary completion2 Sep 2021
Study completion2 Sep 2021

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04899674
Sponsor's protocol ID: 1402-0018
Other IDs: 2020-006052-40
Status last verified: Feb 2025
First submitted: 21 May 2021
Last updated: 24 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
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

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Two-period Fixed Sequence Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of Bupropion in Healthy Volunteers
ClinicalTrials.gov ID: NCT04899674
Acronym / sponsor ID: 1402-0018
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 30 Jun 2021 (actual)
Primary completion: 2 Sep 2021 (actual)
Study completion: 2 Sep 2021 (actual)
First posted: 24 May 2021 (actual)
Results: Posted 24 Feb 2025

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
bupropion alone (Reference (R)) then BI 1358894 + bupropion (Test (T))	Experimental	Drug: Elontril, Drug: BI 1358894

Who may qualify

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

Key inclusion criteria (10 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 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 safety laboratory, 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 beats per minute (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
ElontrilAlso: Bupropion hydrochlorideTablet	Drug	bupropion alone (Reference (R)) then BI 1358894 + bupropion (Test (T))
BI 1358894Film coated tablet	Drug	bupropion alone (Reference (R)) then BI 1358894 + bupropion (Test (T))

Primary outcome

Area Under the Concentration-time Curve of Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. Time Frame: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))". Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Maximum Measured Concentration of Bupropion in Plasma (Cmax)
Time frame: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).
Maximum measured concentration of bupropion in plasma (Cmax) is presented. Timeframe: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))". Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".

1 secondary outcome

Area Under the Concentration-time Curve of Bupropion in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Time frame: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).

Results and safety

Results posted to the registry on 24 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupropion Alone (Reference (R)) Then BI 1358894 + Bupropion (Test (T))	18	18

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

Time frame: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).. Geometric least squares mean (Standard Error). Unit: hours * nanomole/Liter

Measure	Bupropion Alone (Reference (R)) n = 16	BI 1358894 + Bupropion (Test (T)) n = 14
Value	2953 (NA)	2795 (NA)

Bupropion Alone (Reference (R)) vs BI 1358894 + Bupropion (Test (T)): Ratio of gMeans [%]: 94.6 (90% CI 86.3 to 103.8)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

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

Time frame: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).. Geometric least squares mean (Standard Error). Unit: nanomole/Liter

Measure	Bupropion Alone (Reference (R)) n = 16	BI 1358894 + Bupropion (Test (T)) n = 14
Value	262 (NA)	237 (NA)

Bupropion Alone (Reference (R)) vs BI 1358894 + Bupropion (Test (T)): Ratio of gMeans[%]: 90.7 (90% CI 74.3 to 110.7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bupropion	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
BI 1358894	0 of 18 (0%)	9 of 18 (50%)	0 of 18
BI 1358894 + Bupropion	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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

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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 Elontril and BI 1358894 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 10 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: finished, as of the sponsor's last update on 24 Feb 2025. 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 24 Feb 2025). 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 Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).). The study lists 2 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 NCT04899674.

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 24 Feb 2025.