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A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04590937
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
2.7
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the effect of BI 730357 under steady state conditions on the pharmacokinetics of digoxin, furosemide, metformin and rosuvastatin given as a cocktail (Reference, R: cocktail alone; Test T: cocktail given under steady state conditions of BI 730357).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of BI 730357 on the Pharmacokinetics of Rosuvastatin, Digoxin, Metformin and Furosemide Given as a Cocktail - an Open-label, Non-randomised, 2-period Fixed-sequence Trial in Healthy Subjects
Actual Study Start Date :
Oct 20, 2020
Actual Primary Completion Date :
Jan 11, 2021
Actual Study Completion Date :
Jan 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reference

Drug: CRESTOR®
Film-coated tablet

Drug: Lenoxin®
Tablet

Drug: MetfoLiquid GeriaSan®
Oral solution

Drug: Lasix®
Oral solution
Experimental: BI 730357

Drug: BI 730357
Film-coated tablet

Drug: CRESTOR®
Film-coated tablet

Drug: Lenoxin®
Tablet

Drug: MetfoLiquid GeriaSan®
Oral solution

Drug: Lasix®
Oral solution

Outcome Measures

Primary Outcome Measures

  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Up to 8 days]

  2. Cmax (maximum measured concentration of the analyte in plasma) [Up to 8 days]

Secondary Outcome Measures

  1. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the the time interval from 0 to the last quantifiable data point) [Up to 8 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
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), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory Tests

  • Age of 18 to 55 years (inclusive)

  • BMI of 18.5 to 29.9 kilogram per square meter (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 or bilateral tubal occlusion)

  • 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 units per liter (U/L) and estradiol below 30 nanograms per liter (ng/L) is confirmatory)

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 millimetres of Mercury (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

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

  • 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:
NCT04590937
Other Study ID Numbers:
  • 1407-0038
  • 2020-003097-46
First Posted:
Oct 19, 2020
Last Update Posted:
Feb 25, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Rosuvastatin Calcium

Study Results

No Results Posted as of Feb 25, 2021