Finding the best pill form: a drug for COVID-19 complications gets a formulation check
NCT ID NCT04656288
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial studies how the drug BI 764198 is absorbed into the body when given as different pill types (capsules vs. tablets) and with or without food. It involves 28 healthy adults aged 18 to 50. The goal is to find the best oral formulation for future use in patients hospitalized with COVID-19 who are at risk of respiratory complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 764198 (Apecotrep)
- What this could lead to
- If successful, this trial will identify the best way to take BI 764198, potentially improving its use in future studies for COVID-19 patients at risk of breathing problems.
- What could go wrong
- This is an early-stage trial in healthy volunteers, not patients. The drug may not work as hoped in sick people, and side effects are possible.
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
-
28 people
The number who actually took part.
- Started
-
Jan 2021
- Finished
-
Mar 2021
- 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
-
18 to 50 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 assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 50 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 Good Clinical Practice (GCP) and local legislation * Male subjects who meet any of the following criteria from first administration of trial medication until 30 days after trial completion: * Use of adequate contraception by the female partners, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea * Sexually abstinent * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) Sperm donation is not allowed from first study drug administration until 30 days after trial completion. Exclusion Criteria: * Any finding in the medical examination (including BP, PR 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 45 to 90 beats per minute (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 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.
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
-
SGS Belgium NV Research Unit Stuivenberg
Antwerp, 2060, Belgium
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?