HealthyPhase 1NCT03971695

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321

A Phase 1 study testing BI 706321 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.

Trial summary

The main objectives are: Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 706321
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 73 participants
Where: 1 siteGermany
Study dates: 18 Jun 2019to 4 Dec 2020
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR, oral body temperature), 12-lead ECG, and clinical laboratory tests
Age of 18 to 45 years (inclusive) in Part I and of 18 to 55 years (inclusive) in Part II
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 GCP and local legislation

Who cannot join

Any finding in the medical examination (including Blood Pressure (BP), (PR), oral body temperature 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 50 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)

Show all 25Show fewer

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
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 24 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
Inability to comply with the dietary regimen of the trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
ALT (alanine transaminase), AST (aspartate transaminase), or creatinine exceed upper limit of normal range at screening, confirmed by a repeat test
During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection

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: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

The main objectives are:

Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses.
Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.

Conditions: Healthy
Being tested: BI 706321, Placebo

What participants receive

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

BI 706321Drug
Capsule or Oral Solution
PlaceboDrug
Capsule or Oral solution

Study groups in NCT03971695
Study group	Role	What they receive
Part I - Placebo oral solution	Placebo comparator	Part I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms. Receives: Drug: Placebo
Part I - 0.3 mg BI 706321 oral solution	Experimental	Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours Receives: Drug: BI 706321
Part I - 0.6 mg BI 706321 oral solution	Experimental	Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part I - 1.2 mg BI 706321 oral solution	Experimental	Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part I - Placebo capsules	Placebo comparator	Part I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms. Receives: Drug: Placebo
Part I - 2 mg BI 706321 capsules	Experimental	Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part I - 4 mg BI 706321 capsules	Experimental	Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part I - 8 mg BI 706321 capsules	Experimental	Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part I - 15 mg BI 706321 capsules	Experimental	Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part I - 25 mg BI 706321 capsules	Experimental	Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321
Part II - Test 1 (T1), fasted, tablets	Experimental	Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours Receives: Drug: BI 706321
Part II - Test 2 (T2), fed, tablets	Experimental	Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast. Receives: Drug: BI 706321
Part II - Reference (R), fasted, capsules	Experimental	Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 706321

What is being measured

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

Part I: Percentage of Subjects With Drug-related Adverse Events
Part I: Percentage of subjects with drug-related adverse events.
Measured: Between intake of trial medication and the individual subject's end of trial, up to 22 days.
Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Measured: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.
Part II: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
Part II: Maximum measured concentration of BI 706321 in plasma (Cmax).
Measured: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.

Secondary outcomes (4)

Part I: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Part I: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Measured: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.
Part I: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
Part I: Maximum measured concentration of BI 706321 in plasma (Cmax).
Measured: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.
Part I: Time From Dosing to the Maximum Measured Concentration of BI 706321 in Plasma (Tmax)
Part I: Time from dosing to the maximum measured concentration of BI 706321 in plasma (tmax).
Measured: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.
Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Measured: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.

Timeline

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

18 Jun 20194 Dec 2020

First posted3 Jun 2019
Study start18 Jun 2019
Primary completion4 Dec 2020
Study completion4 Dec 2020

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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03971695
Sponsor's protocol ID: 1425-0001
Other IDs: 2019-000888-25, 2019
Status last verified: Aug 2025
First submitted: 31 May 2019
Last updated: 18 Sep 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: http://trials.boehringer-ingelheim.com/

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
ClinicalTrials.gov ID: NCT03971695
Acronym / sponsor ID: 1425-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Jun 2019 (actual)
Primary completion: 4 Dec 2020 (actual)
Study completion: 4 Dec 2020 (actual)
First posted: 3 Jun 2019 (actual)
Results: Posted 18 Sep 2025

Clinical summary

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

The main objectives are:

Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses.
Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 13

Arm	Type	Receives
Part I - Placebo oral solution	Placebo comparator	Drug: PlaceboPart I - Placebo oral solution matching BI 706321 as single dose taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.
Part I - 0.3 mg BI 706321 oral solution	Experimental	Drug: BI 706321Part I - 1.2 mL oral solution of 0.25 mg/mL (0.3 milligram (mg) BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours
Part I - 0.6 mg BI 706321 oral solution	Experimental	Drug: BI 706321Part I - 2.4 mL oral solution of 0.25 mg/mL (0.6 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I - 1.2 mg BI 706321 oral solution	Experimental	Drug: BI 706321Part I - 4.8 mL oral solution of 0.25 mg/mL (1.2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I - Placebo capsules	Placebo comparator	Drug: PlaceboPart I - Placebo capsules BI 706321 as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours. Placebo subjects were randomised in a 3:1 ratio over the matching BI 706321 arms.
Part I - 2 mg BI 706321 capsules	Experimental	Drug: BI 706321Part I - 2 capsules of 1 mg (2 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I - 4 mg BI 706321 capsules	Experimental	Drug: BI 706321Part I - 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I - 8 mg BI 706321 capsules	Experimental	Drug: BI 706321Part I - 8 capsules of 1 mg (8 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I - 15 mg BI 706321 capsules	Experimental	Drug: BI 706321Part I - 3 capsules of 5 mg (15 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part I - 25 mg BI 706321 capsules	Experimental	Drug: BI 706321Part I - 5 capsules of 5 mg (25 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.
Part II - Test 1 (T1), fasted, tablets	Experimental	Drug: BI 706321Part II - Test 1 (T1), fasted: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours
Part II - Test 2 (T2), fed, tablets	Experimental	Drug: BI 706321Part II - Test 2 (T2), fed: 2 tablets of 2 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after a high-fat, high-calorie breakfast.
Part II - Reference (R), fasted, capsules	Experimental	Drug: BI 706321Part II - Reference (R), fasted: 4 capsules of 1 mg (4 mg BI 706321) as single dose taken orally with 240 mL of water after an overnight fast of at least 10 hours.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR, oral body temperature), 12-lead ECG, and clinical laboratory tests
Age of 18 to 45 years (inclusive) in Part I and of 18 to 55 years (inclusive) in Part II
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 GCP and local legislation

Key exclusion criteria (25 listed)

Any finding in the medical examination (including Blood Pressure (BP), (PR), oral body temperature 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 50 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
BI 706321Capsule or Oral Solution	Drug	Part I - 0.3 mg BI 706321 oral solution, Part I - 0.6 mg BI 706321 oral solution, Part I - 1.2 mg BI 706321 oral solution, Part I - 15 mg BI 706321 capsules, Part I - 2 mg BI 706321 capsules, Part I - 25 mg BI 706321 capsules, Part I - 4 mg BI 706321 capsules, Part I - 8 mg BI 706321 capsules, Part II - Reference (R), fasted, capsules, Part II - Test 1 (T1), fasted, tablets, Part II - Test 2 (T2), fed, tablets
PlaceboCapsule or Oral solution	Drug	Part I - Placebo capsules, Part I - Placebo oral solution

Primary outcome

Part I: Percentage of Subjects With Drug-related Adverse Events
Time frame: Between intake of trial medication and the individual subject's end of trial, up to 22 days.
Part I: Percentage of subjects with drug-related adverse events.
Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.
Part II: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Part II: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.
Part II: Maximum measured concentration of BI 706321 in plasma (Cmax).

4 secondary outcomes

Part I: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.
Part I: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.
Part I: Time From Dosing to the Maximum Measured Concentration of BI 706321 in Plasma (Tmax)
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 168 hours after drug administration.
Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.

Results and safety

Results posted to the registry on 18 Sep 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
Part I - Placebo Oral Solution	6	6
Part I - 0.3 mg BI 706321 Oral Solution	6	6
Part I - 0.6 mg BI 706321 Oral Solution	6	6
Part I - 1.2 mg BI 706321 Oral Solution	5	5
Part I - Placebo Capsules	9	9
Part I - 2 mg BI 706321 Capsules	6	6
Part I - 4 mg BI 706321 Capsules	6	6
Part I - 8 mg BI 706321 Capsules	6	6
Part I - 15 mg BI 706321 Capsules	5	5
Part I - 25 mg BI 706321 Capsules	6	6
Part II - R-T1-T2	4	4
Part II - T1-T2-R	4	4
Part II - T2-R-T1	4	4

Primary outcome: Part I: Percentage of Subjects With Drug-related Adverse Events

Time frame: Between intake of trial medication and the individual subject's end of trial, up to 22 days.. Number. Unit: Percentage of participants

Measure	Part I - Placebo Oral Solution n = 6	Part I - 0.3 mg BI 706321 Oral Solution n = 6	Part I - 0.6 mg BI 706321 Oral Solution n = 6	Part I - 1.2 mg BI 706321 Oral Solution n = 5	Part I - Placebo Capsules n = 9	Part I - 2 mg BI 706321 Capsules n = 6	Part I - 4 mg BI 706321 Capsules n = 6	Part I - 8 mg BI 706321 Capsules n = 6	Part I - 15 mg BI 706321 Capsules n = 5	Part I - 25 mg BI 706321 Capsules n = 6
Value	16.7	16.7	0.0	0.0	11.1	0.0	0.0	16.7	20.0	33.3

Population analysed: Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.

Primary outcome: Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 168 hours after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanomol/liter

Measure	Part II - Test 1 (T1), Fasted, Tablets n = 12	Part II - Test 2 (T2), Fed, Tablets n = 12	Part II - Reference (R), Fasted, Capsules n = 12
Value	150 (27.5)	138 (29.9)	150 (29.5)

Part II - Test 1 (T1), Fasted, Tablets vs Part II - Reference (R), Fasted, Capsules: Adjusted geometric mean (gMean) ratio(%): 100.26 (90% CI 90.18 to 111.48)
Part II - Test 1 (T1), Fasted, Tablets vs Part II - Test 2 (T2), Fed, Tablets: Adjusted geometric mean (gMean) ratio(%): 91.63 (90% CI 85.37 to 98.35)

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

Primary outcome: Part II: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)

Measure	Part II - Test 1 (T1), Fasted, Tablets n = 12	Part II - Test 2 (T2), Fed, Tablets n = 12	Part II - Reference (R), Fasted, Capsules n = 12
Value	5.90 (47.8)	4.57 (33.6)	6.02 (41.1)

Part II - Test 1 (T1), Fasted, Tablets vs Part II - Reference (R), Fasted, Capsules: Adjusted geometric mean (gMean) ratio(%): 98.01 (90% CI 84.20 to 114.08)
Part II - Test 1 (T1), Fasted, Tablets vs Part II - Test 2 (T2), Fed, Tablets: Adjusted geometric mean (gMean) ratio(%): 77.52 (90% CI 68.11 to 88.22)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Between (first) intake of trial medication and the time of the next administration of trial medication (Part II) or the individual subject's end of trial (Part I and Part II). Up to 22 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part I - Placebo Oral Solution	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part I - Placebo Capsules	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Part I - 0.3 mg BI 706321 Oral Solution	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part I - 0.6 mg BI 706321 Oral Solution	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part I - 1.2 mg BI 706321 Oral Solution	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Part I - 2 mg BI 706321 Capsules	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part I - 4 mg BI 706321 Capsules	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part I - 8 mg BI 706321 Capsules	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part I - 15 mg BI 706321 Capsules	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Part I - 25 mg BI 706321 Capsules	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part II - Test 1 (T1), Fasted, Tablets	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Part II - Test 2 (T2), Fed, Tablets	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Part II - Reference (R), Fasted, Capsules	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Placebo Total	0 of 15 (0%)	6 of 15 (40%)	0 of 15
BI 706321 Total Part I	0 of 46 (0%)	15 of 46 (32.6%)	0 of 46
Total Part I	0 of 61 (0%)	21 of 61 (34.4%)	0 of 61
BI 706321 Total Part II	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
BI 706321 Total	0 of 58 (0%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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: http://trials.boehringer-ingelheim.com/

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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 BI 706321 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 4 inclusion and 25 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 18 Sep 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. Some participants in this study may receive a placebo. 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 18 Sep 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?

Part I: Percentage of Subjects With Drug-related Adverse Events (time frame: Between intake of trial medication and the individual subject's end of trial, up to 22 days.). 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 NCT03971695.

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 18 Sep 2025.