A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04194645
Collaborator
(none)
66
1
2
14.5
4.6

Study Details

Study Description

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 474121
  • Drug: Placebo
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 Administered as Oral Solution and Tablets to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 474121 as Tablet Versus Oral Solution and Tablet With and Without Food (BA Part)
Actual Study Start Date :
Jan 9, 2020
Actual Primary Completion Date :
Mar 25, 2021
Actual Study Completion Date :
Mar 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 474121

Drug: BI 474121
Single dose

Placebo Comparator: Placebo

Drug: Placebo
Single dose

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects with drug-related adverse events (Single-rising dose (SRD) part) [Up to 15 days]

  2. BA part: 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 96 hours]

  3. BA part: Cmax (maximum measured concentration of the analyte in plasma) [Up to 96 hours]

Secondary Outcome Measures

  1. SRD part: 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 96 hours]

  2. SRD part: Cmax (maximum measured concentration of the analyte in plasma) [Up to 96 hours]

  3. BA part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Up to 96 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 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 45 years (inclusive)

  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:
  • Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator

  • Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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

  • Chronic or relevant acute infections

  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)

  • Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)

  • Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered

  • 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 24 g per day)

  • Drug abuse or positive drug screening

  • Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial

  • Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial

  • Inability to comply with the dietary regimen of the trial site

  • A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms or any other relevant ECG finding at screening)

  • A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)

  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

  • Male subjects with WOCBP partner who are unwilling to use a highly effective method of birth control from time point of administration of trial medication until 30 days thereafter.

Highly effective methods of birth control are:
  • Male subject is sexually abstinent

  • Male subjects is vasectomised (vasectomy at least 1 year prior to enrolment), plus condom in male subject

  • Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)

  • Use of progestogen-only hormonal contraception by female partner that inhibits ovulation (only injectables or implants), plus condom in male subject

  • Use of combined (estrogen and progestogen containing) hormonal contraception by female partner that prevents ovulation (oral, intravaginal or transdermal), plus condom in male subject

  • Female partner is surgically sterilised (including hysterectomy)

  • Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L is confirmatory) Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.

  • ALT (alanine transaminase), AST (aspartate transaminase), or serum creatinine exceed upper limit of normal range at screening, confirmed by a repeat test

  • Orthostatic hypotension during orthostatic testing at Day -3, that the investigator considers to be of clinical relevance (only applicable for Single-rising dose (SRD) part).

  • During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humanpharmakologisches Zentrum Biberach Biberach Germany 88397

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:
NCT04194645
Other Study ID Numbers:
  • 1411-0001
  • 2019-002358-22
First Posted:
Dec 11, 2019
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 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 Apr 13, 2021