A Study in Healthy Men and Women to Test if Taking Different Formulations of BI 730357 Tablets Influences the Amount of BI 730357 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03886272
Collaborator
(none)
43
1
2
2.3
18.4

Study Details

Study Description

Brief Summary

The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI 730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1 (Reference, R).

The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF batch of BI 730357 with regularly milled API (Reference, R).

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 730357 (Test)
  • Drug: BI 730357 (Reference)
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Relative Bioavailability of Intended Commercial Formulations (iCF) of BI 730357 Versus BI 730357 Trial Formulation 1 and Bioavailability Comparison of Three Different iCF Batches Following Oral Administration in Healthy Subjects (an Open-label, Single-dose, Randomised, 2-way and 3-way Crossover Trial)
Actual Study Start Date :
Apr 11, 2019
Actual Primary Completion Date :
Jun 21, 2019
Actual Study Completion Date :
Jun 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 730357 (Test)

Drug: BI 730357 (Test)
tablet

Experimental: BI 730357 (Reference)

Drug: BI 730357 (Reference)
tablet

Outcome Measures

Primary Outcome Measures

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Within 3 hours (h) before and 30 minutes (min), 1h, 1h 30min, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 12h, 24h, 34h, 47h, 71h, 119h, 167h after drug administration.]

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

  2. Maximum measured concentration of the analyte in plasma (Cmax) [Within 3 hours (h) before and 30 minutes (min), 1h, 1h 30min, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 12h, 24h, 34h, 47h, 71h, 119h, 167h after drug administration.]

    Maximum measured concentration of the analyte in plasma (Cmax).

Secondary Outcome Measures

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Within 3 hours (h) before and 30 minutes (min), 1h, 1h 30min, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 12h, 24h, 34h, 47h, 71h, 119h, 167h after drug administration.]

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), PR), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

  • Age of 18 to 50 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

  • Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  • Use of adequate contraception, e.g. any of the following methods plus condom:

--- implants, injectables, combined oral or vaginal contraceptives, intrauterine device

  • Sexually abstinent

  • A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

  • Surgically sterilised (including hysterectomy)

  • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:
  • Any finding in the medical examination (including Blood pressure (BP), 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 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 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 12 g per day for females and 24 g per day for males)

  • 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 in males or repeatedly greater than 470 ms in females) 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

  • Female subjects will not be allowed to participate, if any of the following apply:

-- Positive pregnancy test, pregnancy, or plans to become pregnant within 30 days after study completion

  • Lactation

  • Male subjects with Woman of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of first administration of trial medication until 30 days after the last administration of trial medication

  • Further exclusion criteria apply

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:
NCT03886272
Other Study ID Numbers:
  • 1407-0032
  • 2018-004421-91
First Posted:
Mar 22, 2019
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 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 Nov 11, 2021