A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazolam in the Blood

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04679948
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

The trial will be performed to assess the influence of BI 730357 on the pharmacokinetics of caffeine, warfarin, omeprazole and midazolam.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Drug Cocktail consisting of caffeine, warfarin, omeprazole and midazolam; Drug: BI 730357	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Two Periods (Period 1 and Period 2) for each participant.Two Periods (Period 1 and Period 2) for each participant.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Multiple Doses of BI 730357 on the Single Dose Pharmacokinetics of Caffeine, Warfarin, Omeprazole and Midazolam Administered Orally as a Cocktail in Healthy Subjects (an Open-label, Two-period Fixed Sequence Design Trial)
• Actual Study Start Date: Dec 21, 2020
• Actual Primary Completion Date: Mar 17, 2021
• Actual Study Completion Date: Mar 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Period 1 with reference treatment alone	Drug: Drug Cocktail consisting of caffeine, warfarin, omeprazole and midazolam; Reference Treatment R
Experimental: Period 2 with reference and test treatment	Drug: Drug Cocktail consisting of caffeine, warfarin, omeprazole and midazolam; Reference Treatment R; Drug: BI 730357; BI 730357, Test treatment T

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) for caffeine [up to 7 days]

2. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for warfarin [up to 7 days]

3. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for omeprazole [up to 7 days]

4. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for midazolam [up to 7 days]

5. Cmax (maximum measured concentration of the analyte in plasma) for caffeine [up to 7 days]

6. Cmax (maximum measured concentration of the analyte in plasma) for warfarin [up to 7 days]

7. Cmax (maximum measured concentration of the analyte in plasma) for omeprazole [up to 7 days]

8. Cmax (maximum measured concentration of the analyte in plasma) for midazolam [up to 7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 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), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

• Age of 18 to 55 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 GCP and local legislation

• Either male subject, or female subject 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 non-hormonal intrauterine device plus condom for birth control

• 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 U/L and estradiol below 30 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 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 (except appendectomy or simple hernia repair) that could interfere with the pharmacokinetics (PK) of the trial medication

• 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 inclusion 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:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04679948
• Other Study ID Numbers: 1407-0039; 2020-002506-51
• First Posted: Dec 22, 2020
• Last Update Posted: Mar 19, 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: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Midazolam; Caffeine; Omeprazole; Warfarin

Study Results

No Results Posted as of Mar 19, 2021