NCT03971695 is a Phase 1 clinical trial of BI 706321 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03971695?

NCT03971695 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03971695?

Interventions in NCT03971695: BI 706321, Placebo.

Is NCT03971695 still recruiting?

NCT03971695 is currently completed. Last updated 18 September 2025.

Are results published for NCT03971695?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-18 · How we verify

NCT03971695

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 18 September 2025

What this trial tests

Phase 1 trial testing BI 706321 in Healthy in 73 participants. Completed in 4 December 2020.

Timeline

18 June 2019

Primary endpoint
4 December 2020

4 December 2020

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	73
Start date	18 June 2019
Primary completion	4 December 2020
Estimated completion	4 December 2020
Sites	1 location across Germany

Drugs / interventions tested

BI 706321 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Part I - Placebo Oral Solution	16.7
Part I - 0.3 mg BI 706321 Oral Solution	16.7
Part I - 0.6 mg BI 706321 Oral Solution	0.0
Part I - 1.2 mg BI 706321 Oral Solution	0.0
Part I - Placebo Capsules	11.1
Part I - 2 mg BI 706321 Capsules	0.0
Part I - 4 mg BI 706321 Capsules	0.0
Part I - 8 mg BI 706321 Capsules	16.7
Part I - 15 mg BI 706321 Capsules	20.0
Part I - 25 mg BI 706321 Capsules	33.3

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) Primary · 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).

Group	Value	95% CI
Part II - Test 1 (T1), Fasted, Tablets	150	± 27.5
Part II - Test 2 (T2), Fed, Tablets	138	± 29.9
Part II - Reference (R), Fasted, Capsules	150	± 29.5

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

Group	Value	95% CI
Part II - Test 1 (T1), Fasted, Tablets	5.90	± 47.8
Part II - Test 2 (T2), Fed, Tablets	4.57	± 33.6
Part II - Reference (R), Fasted, Capsules	6.02	± 41.1

Part I: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Secondary · 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: Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Group	Value	95% CI
Part I - 0.3 mg BI 706321 Oral Solution	NA	± NA
Part I - 0.6 mg BI 706321 Oral Solution	NA	± NA
Part I - 1.2 mg BI 706321 Oral Solution	NA	± NA
Part I - 2 mg BI 706321 Capsules	NA	± NA
Part I - 4 mg BI 706321 Capsules	151	± 33.1
Part I - 8 mg BI 706321 Capsules	314	± 25.7
Part I - 15 mg BI 706321 Capsules	618	± 36.1
Part I - 25 mg BI 706321 Capsules	1130	± 24.2

Part I: Maximum Measured Concentration of BI 706321 in Plasma (Cmax) Secondary · 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).

Group	Value	95% CI
Part I - 0.3 mg BI 706321 Oral Solution	0.388	± 32.8
Part I - 0.6 mg BI 706321 Oral Solution	0.781	± 21.4
Part I - 1.2 mg BI 706321 Oral Solution	1.02	± 40.0
Part I - 2 mg BI 706321 Capsules	2.27	± 30.1
Part I - 4 mg BI 706321 Capsules	5.19	± 38.6
Part I - 8 mg BI 706321 Capsules	11.8	± 41.6
Part I - 15 mg BI 706321 Capsules	24.6	± 43.0
Part I - 25 mg BI 706321 Capsules	41.1	± 32.1

Part I: Time From Dosing to the Maximum Measured Concentration of BI 706321 in Plasma (Tmax) Secondary · 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).

Group	Value	95% CI
Part I - 0.3 mg BI 706321 Oral Solution	5.61	± 16.7
Part I - 0.6 mg BI 706321 Oral Solution	5.25	± 51.6
Part I - 1.2 mg BI 706321 Oral Solution	5.22	± 31.8
Part I - 2 mg BI 706321 Capsules	5.24	± 51.6
Part I - 4 mg BI 706321 Capsules	4.91	± 22.3
Part I - 8 mg BI 706321 Capsules	4.12	± 43.7
Part I - 15 mg BI 706321 Capsules	3.37	± 70.7
Part I - 25 mg BI 706321 Capsules	3.64	± 62.1

Part II: Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Secondary · 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 extrapolated to infinity (AUC0-∞).

Group	Value	95% CI
Part II - Test 1 (T1), Fasted, Tablets	169	± 26.1
Part II - Test 2 (T2), Fed, Tablets	154	± 28.0
Part II - Reference (R), Fasted, Capsules	171	± 27.7

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part I - Placebo Oral Solution

Serious: 0/6 (0%)

Deaths: 0/6

Part I - Placebo Capsules

Serious: 0/9 (0%)

Deaths: 0/9

Part I - 0.3 mg BI 706321 Oral Solution

Serious: 0/6 (0%)

Deaths: 0/6

Part I - 0.6 mg BI 706321 Oral Solution

Serious: 0/6 (0%)

Deaths: 0/6

Part I - 1.2 mg BI 706321 Oral Solution

Serious: 0/5 (0%)

Deaths: 0/5

Part I - 2 mg BI 706321 Capsules

Serious: 0/6 (0%)

Deaths: 0/6

Part I - 4 mg BI 706321 Capsules

Serious: 0/6 (0%)

Deaths: 0/6

Part I - 8 mg BI 706321 Capsules

Serious: 0/6 (0%)

Deaths: 0/6

Part I - 15 mg BI 706321 Capsules

Serious: 0/5 (0%)

Deaths: 0/5

Part I - 25 mg BI 706321 Capsules

Serious: 0/6 (0%)

Deaths: 0/6

Part II - Test 1 (T1), Fasted, Tablets

Serious: 0/12 (0%)

Deaths: 0/12

Part II - Test 2 (T2), Fed, Tablets

Serious: 0/12 (0%)

Deaths: 0/12

Part II - Reference (R), Fasted, Capsules

Serious: 0/12 (0%)

Deaths: 0/12

Placebo Total

Serious: 0/15 (0%)

Deaths: 0/15

BI 706321 Total Part I

Serious: 0/46 (0%)

Deaths: 0/46

Total Part I

Serious: 0/61 (0%)

Deaths: 0/61

BI 706321 Total Part II

Serious: 0/12 (0%)

Deaths: 0/12

BI 706321 Total

Serious: 0/58 (0%)

Deaths: 0/58

Total

Serious: 0/73 (0%)

Deaths: 0/73

Other adverse events (24 terms — click to expand)

Reaction	System	Part I - Placebo Oral Solu…	Part I - Placebo Capsules	Part I - 0.3 mg BI 706321 …	Part I - 0.6 mg BI 706321 …	Part I - 1.2 mg BI 706321 …	Part I - 2 mg BI 706321 Ca…	Part I - 4 mg BI 706321 Ca…	Part I - 8 mg BI 706321 Ca…	Part I - 15 mg BI 706321 C…	Part I - 25 mg BI 706321 C…	Part II - Test 1 (T1), Fas…	Part II - Test 2 (T2), Fed…	Part II - Reference (R), F…	Placebo Total	BI 706321 Total Part I	Total Part I	BI 706321 Total Part II	BI 706321 Total	Total
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Photokeratitis	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lip dry	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling cold	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pre-existing condition improved	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Puncture site reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Scar	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myosclerosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03971695 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of BI 706321

Trials testing the same drug.

NCT05183360 — A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated · Phase 1 · terminated
NCT04978493 — A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease · Phase 2 · terminated
NCT04714073 — A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03971695 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 18 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03971695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03971695

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of BI 706321

Other recruiting trials for Healthy

Other Boehringer Ingelheim trials

Verify against primary sources