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A Study in Healthy Men to Test if Different Formulations of BI 764198 With or Without Food Influence the Amount of BI 764198 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04656288
Collaborator
(none)
28
Enrollment
1
Location
6
Arms
1.9
Actual Duration (Months)
14.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory complications. The present trial will investigate the relative bioavailability of BI 764198 administered as capsules versus tablets in a first part, and the relative bioavailability and food effect of four oral formulations: the newly developed tablet formulation under fed and fasted conditions as well as suspension from capsules and suspension from tablets in a second part.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 764198 - Formula A
  • Drug: BI 764198 - Formula B
  • Drug: BI 764198 - Formula C
  • Drug: BI 764198 - Formula D
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Two-part Phase I Trial Investigating the Relative Bioavailability and Food Effect of Different Oral Formulations of BI 764198 in Healthy Subjects (an Open-label, Single-dose, Randomised, Crossover Study)
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
Mar 15, 2021
Actual Study Completion Date :
Mar 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Formula A under fasted conditions - Part 1

Drug: BI 764198 - Formula A
BI 764198
Experimental: Formula B under fasted conditions - Part 1

Drug: BI 764198 - Formula B
BI 764198
Experimental: Formula B under fasted conditions - Part 2

Drug: BI 764198 - Formula B
BI 764198
Experimental: Formula C under fasted conditions - Part 2

Drug: BI 764198 - Formula C
BI 764198
Experimental: Formula D under fasted conditions - Part 2

Drug: BI 764198 - Formula D
BI 764198
Experimental: Formula B under fed conditions - Part 2

Drug: BI 764198 - Formula B
BI 764198

Outcome Measures

Primary Outcome Measures

  1. 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) [up to 4 days per period]

  2. Part 1: Cmax (maximum measured concentration of the analyte in plasma) [up to 4 days per period]

  3. 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) [up to 5 days per period]

  4. Part 2: Cmax (maximum measured concentration of the analyte in plasma) [up to 5 days per period]

Secondary Outcome Measures

  1. Part 1: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 4 days per period]

  2. Part 2: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 5 days per period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 SGS Belgium NV Research Unit Stuivenberg Antwerpen Belgium 2060

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04656288
Other Study ID Numbers:
  • 1434-0010
  • 2020-004757-79
First Posted:
Dec 7, 2020
Last Update Posted:
Mar 22, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 22, 2021