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

NCT03971695 | Completed Phase 1 Results

• 2 other identifiers: 1425-00012019-000888-25
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.
• 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

Outcome Measures

Primary Outcomes (3)

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

  Part I: Percentage of subjects with drug-related adverse events.

  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).

  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).

  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-∞)

  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)

  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)

  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-∞)

  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.

Study Arms (13)

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

Drug: BI 706321

Interventions

BI 706321 DRUG

Capsule or Oral Solution

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

Placebo DRUG

Capsule or Oral solution

Part I - Placebo capsules; Part I - Placebo oral solution

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 3, 2019
• Study Start: June 18, 2019
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)