COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04656288

Not reported

Not reported

2020-12-07

Completed

RCT

Randomized

Crossover

Open label

single-center

Prevention

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.

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.

6

Boehringer Ingelheim

18

50

Belgium

Healthy volunteers

N/A

28

Part 1: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point);Part 1: Cmax (maximum measured concentration of the analyte in plasma);Part 2: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point);Part 2: Cmax (maximum measured concentration of the analyte in plasma)

None

Phase 1

[{"arm_notes": "Formula A under fasted conditions - Part 1", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Formula B under fasted conditions - Part 1", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Formula B under fasted conditions - Part 2", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Formula C under fasted conditions - Part 2", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Formula D under fasted conditions - Part 2", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Formula B under fed conditions - Part 2", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]