Experimental drug BI 706321 tested in healthy men – study halted early
NCT ID NCT05183360
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety and how the body processes a new drug called BI 706321 in healthy Japanese and Chinese men. The study was terminated early, so no results are available. It was designed to check for side effects and measure drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 706321
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
48 people
The number who actually took part.
- Started
-
Feb 2022
- Finished
-
Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 45 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Further exclusion criteria apply
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a chewable postbiotic tablet keep plaque and gum inflammation at bay?
- Can a new oral drug safely help older adults manage weight?
- Can a protein powder with creatine and fiber boost everyday Well-Being?
- Green tech or hidden stress? bus Drivers' hearts monitored behind the wheel
- Shout it out: can growls and screams raise pain tolerance?
- Scientists probe why brain stimulation works for some and not others