New drug tested in healthy volunteers – no cure expected
NCT ID NCT02383888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested the safety and how the body handles a single dose of an experimental drug called BI 425809 in 49 healthy Japanese and Chinese men. Participants received either the drug or a placebo, and researchers monitored side effects and drug levels in the blood. Since this was a Phase 1 study in healthy volunteers, it does not aim to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 425809 (Iclepertin)
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
-
49 people
The number who actually took part.
- Started
-
May 2015
- Finished
-
Aug 2015
- 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
-
Accepted
You do not need to have the condition being studied to take part.
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 investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests * Age 20 to 45 years (incl.) * BMI 18.5 to 25 kg/m2 (incl.) * Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation * Chinese ethnicity, Japanese ethnicity according to the following criteria: * Chinese: ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China * Japanese: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan Exclusion criteria: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator * Repeated measurement of systolic blood pressure \<90 or \>140 mmHg, or diastolic blood pressure \<50 or \>90 mmHg, or PR \<50 or \>90 * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication * Diseases of the central nervous system (including by not limited to any kind of seizures or stroke), other neurological disorders or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts * Chronic or relevant acute infections * History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients) * Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half- lives of the respective drug prior to administration of trial medication * Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval * Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication * 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 20 g per day) * Drug abuse or positive drug screening * Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial * Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial * Inability to comply with dietary regimen of trial site * At screening, a marked baseline prolongation of QT/QTcF interval (such as repeated demonstration of a QTcF interval greater than 450 ms or any other relevant ECG finding * A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome) * Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study * Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month) * Evidence or history of macular degeneration or any abnormal finding in color discrimination test, and any other clinically significant ophthalmic disorders based on the investigator's discretion
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
1346.4.82001 Boehringer Ingelheim Investigational Site
Busan, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The effects of external nasal dilator strips on sleep and cardiovascular health
- A pharmacokinetic study of NTI164 in healthy adult volunteers
- Genetic determinants of Exercise-Induced muscle damage (POLYGENDOMUS) / déterminants génétiques des dommages musculaires induits par l'Exercice (POLYGENDOMUS)
- Can a simple injection timing reduce bleeding after skin cancer surgery?
- Can Land-Based teachings shape psychedelic therapy training?
- Can a new oral drug pass early safety tests?