Trial Outcomes & Findings for A Study in Healthy Men to Test Whether BI 1358894 Reduces Druginduced Panic Symptoms (NCT NCT03904576)

Last Updated: 2025-03-19

Results Overview

The last value before administration of the CCK-4 challenge in each period was considered the corresponding period baseline measurement. The PSS sum intensity score mean value of the two period baseline values was considered as the subject baseline. The PSS is a patient reported outcome measurement from which the following factors where derived: physical symptoms of fear and the perception of alertness, anxiety, fear, and pain. The subjects were asked to rate each of 18 characteristic questions on a scale from 0 (absent) to 4 (very strong). The sum of the scale over all items constituted the PSS sum intensity score, ranging from 0 to 72. A higher score implies a stronger panic symptom.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Within 3 hours (h) prior trial medication administration and 4h, 4h 45 minutes (min), 5h 5min, 5h 10min, 5h 20min, 5h 30min and 192h thereafter.

Results posted on

2025-03-19

Participant Flow

A double-blind, randomized, two-way cross-over, single-dose, placebo-controlled trial to investigate the effects of BI 1358894 on cholecystokinin tetrapeptide (CCK-4) induced panic symptoms in healthy male subjects.

All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion and non of the exclusion criteria. Participants were not to be entered to trial treatment in any of the specific entry criteria were not met.

Participant milestones

Participant milestones
Measure	100 mg BI 1358894 (T) / Placebo (R) 4 film-coated tablets of 25 milligram (mg) of BI 1358894 were administered as a single oral dose with 240 milliliter (mL) of water after a standard high-fat meal as test treatment (T), followed by a washout period of at least 17 days, followed by 4 placebo film-coated tablets, administered as a single oral dose with 240 mL of water after a standard high-fat meal, as reference treatment (R). Treatments were administered 5 hours (h) prior to the provoking agent cholecystokinin tetrapeptide (CCK-4). CCK-4 was administered in 2 single doses of 50 microgram (μg) intravenous via bolus injection.	Placebo (R) /100 mg BI 1358894 (T) 4 film-coated tablets of matching placebo were administered as a single oral dose with 240 milliliter (mL) of water after a standard high-fat meal as reference treatment (R), followed by a washout period of at least 17 days, followed by 4 film-coated tablets of 25 mg of BI 1358894, administered as a single oral dose with 240 mL of water after a standard high-fat meal, as test treatment (T). Treatments were administered 5 h prior to the provoking agent CCK-4. CCK-4 was administered in 2 single doses of 50 μg intravenous via bolus injection.
Treatment Period 1 STARTED	10	10
Treatment Period 1 COMPLETED	10	10
Treatment Period 1 NOT COMPLETED	0	0
Washout Period STARTED	10	10
Washout Period COMPLETED	9	9
Washout Period NOT COMPLETED	1	1
Treatment Period 2 STARTED	9	9
Treatment Period 2 COMPLETED	9	9
Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	100 mg BI 1358894 (T) / Placebo (R) 4 film-coated tablets of 25 milligram (mg) of BI 1358894 were administered as a single oral dose with 240 milliliter (mL) of water after a standard high-fat meal as test treatment (T), followed by a washout period of at least 17 days, followed by 4 placebo film-coated tablets, administered as a single oral dose with 240 mL of water after a standard high-fat meal, as reference treatment (R). Treatments were administered 5 hours (h) prior to the provoking agent cholecystokinin tetrapeptide (CCK-4). CCK-4 was administered in 2 single doses of 50 microgram (μg) intravenous via bolus injection.	Placebo (R) /100 mg BI 1358894 (T) 4 film-coated tablets of matching placebo were administered as a single oral dose with 240 milliliter (mL) of water after a standard high-fat meal as reference treatment (R), followed by a washout period of at least 17 days, followed by 4 film-coated tablets of 25 mg of BI 1358894, administered as a single oral dose with 240 mL of water after a standard high-fat meal, as test treatment (T). Treatments were administered 5 h prior to the provoking agent CCK-4. CCK-4 was administered in 2 single doses of 50 μg intravenous via bolus injection.
Washout Period Protocol Violation	1	1

Baseline Characteristics

A Study in Healthy Men to Test Whether BI 1358894 Reduces Druginduced Panic Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 mg BI 1358894 (T) / Placebo (R) n=10 Participants 4 film-coated tablets of 25 milligram (mg) of BI 1358894 were administered as a single oral dose with 240 milliliter (mL) of water after a standard high-fat meal as test treatment (T), followed by a washout period of at least 17 days, followed by 4 placebo film-coated tablets, administered as a single oral dose with 240 mL of water after a standard high-fat meal, as reference treatment (R). Treatments were administered 5 hours (h) prior to the provoking agent cholecystokinin tetrapeptide (CCK-4). CCK-4 was administered in 2 single doses of 50 microgram (μg) intravenous via bolus injection.	Placebo (R) / 100 mg BI 1358894 (T) n=10 Participants 4 film-coated tablets of matching placebo were administered as a single oral dose with 240 milliliter (mL) of water after a standard high-fat meal as reference treatment (R), followed by a washout period of at least 17 days, followed by 4 film-coated tablets of 25 mg of BI 1358894, administered as a single oral dose with 240 mL of water after a standard high-fat meal, as test treatment (T). Treatments were administered 5 h prior to the provoking agent CCK-4. CCK-4 was administered in 2 single doses of 50 μg intravenous via bolus injection.	Total n=20 Participants Total of all reporting groups
Age, Continuous	26.3 Years STANDARD_DEVIATION 10.0 • n=5 Participants	27.0 Years STANDARD_DEVIATION 9.5 • n=7 Participants	26.7 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 hours (h) prior trial medication administration and 4h, 4h 45 minutes (min), 5h 5min, 5h 10min, 5h 20min, 5h 30min and 192h thereafter.

Population: Pharmacodynamic set (PDS): All participants in the treated set (TS) who provided at least one primary pharmacodynamic parameter that was not excluded (due to protocol deviation or due to non-evaluability).

Outcome measures

Outcome measures
Measure	100 mg BI 1358894 (T) n=19 Participants 4 film-coated tablets of 25 milligram (mg) of BI 1358894 were orally administered with 240 milliliter (mL) of water after a standard high-fat meal as test treatment (T). The test treatment was administered 5 hours (h) prior to the provoking agent cholecystokinin tetrapeptide (CCK-4). 50 microgram (μg) CCK-4 were administered intravenous via bolus injection.	Placebo (R) n=19 Participants 4 film-coated tablets of matching placebo were orally administered with 240 milliliter (mL) of water after a standard high-fat meal as reference treatment (R).The reference treatment was administered 5 hours (h) prior to the provoking agent CCK-4. 50 μg CCK-4 were administered intravenous via bolus injection.
Maximum Change From Baseline in Panic Symptom Scale (PSS) Sum Intensity Score	22.639 Score on a scale Standard Error 2.880	29.944 Score on a scale Standard Error 2.884

Adverse Events

100 mg BI 1358894

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	100 mg BI 1358894 n=19 participants at risk 4 film-coated tablets of 25 milligram (mg) of BI 1358894 were orally administered with 240 milliliter (mL) of water after a standard high-fat meal as test treatment (T). The test treatment was administered 5 hours (h) prior to the provoking agent cholecystokinin tetrapeptide (CCK-4). 50 microgram (μg) CCK-4 were administered intravenous via bolus injection.	Placebo n=19 participants at risk 4 film-coated tablets of matching placebo were orally administered with 240 milliliter (mL) of water after a standard high-fat meal as reference treatment (R).The reference treatment was administered 5 hours (h) prior to the provoking agent CCK-4. 50 μg CCK-4 were administered intravenous via bolus injection.
Blood and lymphatic system disorders Lymphadenopathy	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Gastrointestinal disorders Constipation	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Gastrointestinal disorders Dry mouth	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Gastrointestinal disorders Nausea	10.5% 2/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	10.5% 2/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Gastrointestinal disorders Vomiting	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Catheter site induration	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Catheter site pain	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Catheter site paraesthesia	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Fatigue	15.8% 3/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Feeling hot	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Influenza like illness	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Medical device site irritation	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
General disorders Vessel puncture site bruise	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Infections and infestations Nasopharyngitis	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Investigations Liver function test abnormal	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Metabolism and nutrition disorders Decreased appetite	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Nervous system disorders Dizziness	10.5% 2/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Nervous system disorders Dizziness postural	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Nervous system disorders Headache	52.6% 10/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Nervous system disorders Restless legs syndrome	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Nervous system disorders Somnolence	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Psychiatric disorders Agitation	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Psychiatric disorders Dissociative disorder	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Psychiatric disorders Insomnia	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Skin and subcutaneous tissue disorders Dry skin	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.
Skin and subcutaneous tissue disorders Skin irritation	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.	5.3% 1/19 • From drug Administration until end of Trial, up to 40 days. Treated Set: All participants that underwent screening procedures, entered the trial, and were documented to have received at least one dose of investigational study drug.