A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated

NCT ID: NCT05183360

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2024-08-08

Brief Summary

Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses.

Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Matching BI 706321 (Part I)

This trial consisted of two parts: a single-dose part and a multiple-dose part.

Single-Dose Part:

On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.

Multiple-Dose Part:

From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, tablet, oral use

2 mg BI 706321 (Part I)

This trial consisted of two parts: a single-dose part and a multiple-dose part.

Single-Dose Part:

On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.

Multiple-Dose Part:

From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321.

Group Type: EXPERIMENTAL

BI 706321

Intervention Type: DRUG

BI 706321, tablet, oral use

5 mg BI 706321 (Part I)

This trial consisted of two parts: a single-dose part and a multiple-dose part.

Single-Dose Part:

On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.

Multiple-Dose Part:

From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321.

Group Type: EXPERIMENTAL

BI 706321

Intervention Type: DRUG

BI 706321, tablet, oral use

8 mg BI 706321 (Part I)

This trial consisted of two parts: a single-dose part and a multiple-dose part.

Single-Dose Part:

On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.

Multiple-Dose Part:

From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321.

Group Type: EXPERIMENTAL

BI 706321

Intervention Type: DRUG

BI 706321, tablet, oral use

10 mg BI 706321 (Part I)

This trial consisted of two parts: a single-dose part and a multiple-dose part.

Single-Dose Part:

On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.

Multiple-Dose Part:

From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321.

Group Type: EXPERIMENTAL

BI 706321

Intervention Type: DRUG

BI 706321, tablet, oral use

Interventions

BI 706321

BI 706321, tablet, oral use

Intervention Type: DRUG

Placebo

Placebo, tablet, oral use

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male 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) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
• Part I: Japanese ethnicity, according to the following criteria:

-- born in Japan, have lived outside of Japan <10 years

• Part II: Chinese ethnicity including Taiwanese, according to the following criteria:

-- have parents and grandparents who are Chinese

• Age of 20 to 45 years (inclusive) at screening visit
• Body mass index (BMI) of 18.5 to 25.0kg/m2 (inclusive) at screening visit
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
• Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception methods throughout the trial and until three months after the last administration of trial medication. Adequate methods are:

• A vasectomy performed at least 1 year prior to screening and with medical assessment of the surgical success or
• Surgical sterilization, including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy, of the subject's female partner or
• The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), or hormonal contraception, such as implants and injectables, combined with oral or vaginal contraceptives, that started at least 2 months prior to first drug administration, or barrier method, e.g., diaphragm with spermicide

Exclusion Criteria

• Any finding in the medical examination (including BP, PR, body temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 bpm at screening visit
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
• 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, per investigator judgement
• History of relevant orthostatic hypotension, fainting spells, or blackouts

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

1425-0008

Identifier Type: -

Identifier Source: org_study_id