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

NCT04241458 | Completed Phase 1 Results

• 2 other identifiers: 1425-00022019-004351-36
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 706321 in healthy male and female subjects following oral administration of multiple rising doses for 14 days.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Drug-related Adverse Events

  Number of subjects with drug-related adverse events is presented.

  From first administration of study drug until 8 days after the last dosing, up to 27 days.

Secondary Outcomes (5)

• Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

  From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h, 456h after dosing on Day 1.

• Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

  From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1.

• Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss)

  From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1.

• Accumulation Ratio Based on Cmax,ss (RA,Cmax)

  Within 3 hours (h) prior to drug administration on Day 1 and 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 432.5h, 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1.

• Accumulation Ratio Based on AUC0-τ (RA,AUC)

  Within 3 hours (h) prior to drug administration on Day 1 and 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 432.5h, 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1.

Study Arms (5)

2 mg BI 706321

EXPERIMENTAL

Subjects were orally administered a single daily dose of 2 x 1 capsule of 1 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h).

Drug: BI 703621

5 mg BI 706321

EXPERIMENTAL

Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h).

Drug: BI 703621

8 mg BI 706321 + 75 ug midazolam

EXPERIMENTAL

Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) and 3 capsules of 1 mg of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h).

Drug: BI 703621; Drug: Midazolam

10 mg BI 706321+ 75 ug midazolam

EXPERIMENTAL

Subjects were orally administered a single daily dose of 2 capsules of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h).

Drug: BI 703621; Drug: Midazolam

Placebo

PLACEBO COMPARATOR

Subjects were orally administered a single daily dose of matching placebo to BI 706321 capsules on Day 1 and from Day 6 to 19. Three out of the seven subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h).

Drug: Placebo

Interventions

BI 703621 DRUG

BI 703621

10 mg BI 706321+ 75 ug midazolam; 2 mg BI 706321; 5 mg BI 706321; 8 mg BI 706321 + 75 ug midazolam

Placebo DRUG

Placebo

Placebo

Midazolam DRUG

Midazolam

10 mg BI 706321+ 75 ug midazolam; 8 mg BI 706321 + 75 ug midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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), temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive, at screening)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive, at screening)
• 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 BP, PR, 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 45 to 90 mmHg, or pulse rate outside the range of 45 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 30 days (or 5 half-lives (whichever longer)) of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• Smoker of more than 10 cigarettes or 3 cigars or 3 pipes per day
• Inability to refrain from smoking while in-house stay
• Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males), and unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 7 post trial medication administration.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: January 30, 2020
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)