A Study in Healthy Men to Test the Influence of BI 1358894 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood

NCT04099732 | Completed Phase 1 Results

• 2 other identifiers: 1402-00092019-002763-10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1358894 (Test 1, Test 2) following oral administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test 1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

  Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

• Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax)

  Maximum measured concentration of the analyte (rosuvastatin) in Plasma (Cmax). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test 1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

  Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (T1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

• Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

  Dabigatran (2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

• Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax)

  Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax). Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

  Dabigatran (R2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

Secondary Outcomes (2)

• Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (T1): within 3 hours before and up to 96 hours after drug administration. .Detailed time frame is in description section.

• Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Dabigatran (R2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

Study Arms (2)

Part 1: Reference 1 followed by Test 1

EXPERIMENTAL

Reference 1 - Rosuvastatin. Test 1 - Rosuvastatin + BI 1358894

Drug: Rosuvastatin; Drug: BI 1358894

Part 2: Reference 2 followed by Test 2

EXPERIMENTAL

Reference 2 - Dabigatran etexilate. Test 2 - Dabigatran etexilate + BI 1358894

Drug: BI 1358894; Device: Dabigatran etexilate

Interventions

Rosuvastatin DRUG

Tablet

Part 1: Reference 1 followed by Test 1

BI 1358894 DRUG

Tablet

Part 1: Reference 1 followed by Test 1; Part 2: Reference 2 followed by Test 2

Dabigatran etexilate DEVICE

Capsule

Part 2: Reference 2 followed by Test 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• 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 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 (including positive or missing faecal occult blood test in Part 2, retest allowed)
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Rosuvastatin Calcium; TRPC inhibitor BI 1358894

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 23, 2019
• Study Start: October 7, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)