HealthyPhase 1NCT04257032

A Study in Healthy Men to Test the Influence of BI 1323495 on the Amount of the Medicines Rosuvastatin and Dabigatran in the Blood

A Phase 1 study testing Rosuvastatin, Rosuvastatin + BI 1323495 and Dabigatran etexilate in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objectives of this trial are to investigate the relative bioavailabilities of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1323495 (Test 1, Test 2) following oral administration. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rosuvastatin, Rosuvastatin + BI 1323495 and Dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteGermany
Study dates: 13 Feb 2020to 23 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
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
Subjects genotyped as Uridine 5'-diphospho-Glucuronosyltransferase-2B17 (UGT2B17) extensive metabolisers, i.e. carrying at least one functional allele of UGT2B17 gene (*1/*1 or *1/*2)

Who cannot join

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 (including positive or missing faecal occult blood test in Part 2)
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)

Show all 27Show fewer

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 medications or their excipients)
Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial or compromise the subject's safety by participation in the trial (e. g. use of any drug that could reasonably inhibit platelet aggregation or coagulation, concomitant treatment with systemic cyclosporine, ketoconazole, itraconazole and dronedarone, use of fibrates or drugs that cause QT/QTc interval prolongation (QTc: QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB))
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 women of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
Active clinically relevant bleeding or subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of blood coagulation disorders, current or recent gastrointestinal ulceration, presence of malignant neoplasms, recent brain or spinal injury, recent brain/spinal/ophthalmic surgery, recent intracranial hemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities
For Part 1 only: known myopathy, personal or family history of hereditary muscular disorders, or history of muscular toxicity with statins or fibrate; Asian ancestry; hypothyroidism
Subjects with any other condition that would preclude administration of rosuvastatin or dabigatran (i.e. contraindicated as per SmPC), such as active liver disease including elevations of serum transaminases exceeding 2 times the upper limit of normal, moderate or severe renal impairment (creatinine clearance < 60 ml/min based on estimated glomerular filtration rate (GFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula), prosthetic heart valves requiring anticoagulant treatment
During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part)

Conditions: Healthy
Being tested: Rosuvastatin, Rosuvastatin + BI 1323495, Dabigatran etexilate, Dabigatran etexilate + BI 1323495

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Tablet
Rosuvastatin + BI 1323495Drug
Tablets
Dabigatran etexilateDrug
Capsule
Dabigatran etexilate + BI 1323495Drug
Capsule and tablets

Study groups in NCT04257032
Study group	Role	What they receive
Reference 1 (R1)	Experimental	Not described Receives: Drug: Rosuvastatin
Test 1 (T1)	Experimental	Not described Receives: Drug: Rosuvastatin + BI 1323495
Reference 2 (R2)	Experimental	Not described Receives: Drug: Dabigatran etexilate
Test 2 (T2)	Experimental	Not described Receives: Drug: Dabigatran etexilate + BI 1323495

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: 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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Measured: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in 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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Measured: Measured within 3 hours (h) before and up to 95h 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 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 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Measured: Measured within 3 hours (h) before and up to 95h 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 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Measured: Measured within 3 hours (h) before and up to 95h 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)
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 (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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Measured: Measured within 3 hours (h) before and up to 95h 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)
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 (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Measured: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 202023 Sep 2020

First posted5 Feb 2020
Study start13 Feb 2020
Primary completion23 Sep 2020
Study completion23 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04257032
Sponsor's protocol ID: 1405-0015
Other IDs: 2019-004245-33, 2019
Status last verified: Jul 2023
First submitted: 4 Feb 2020
Last updated: 23 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: https://www.mystudywindow.com/msw/datasharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part)
ClinicalTrials.gov ID: NCT04257032
Acronym / sponsor ID: 1405-0015
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 13 Feb 2020 (actual)
Primary completion: 23 Sep 2020 (actual)
Study completion: 23 Sep 2020 (actual)
First posted: 5 Feb 2020 (actual)
Results: Posted 23 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Reference 1 (R1)	Experimental	Drug: Rosuvastatin
Test 1 (T1)	Experimental	Drug: Rosuvastatin + BI 1323495
Reference 2 (R2)	Experimental	Drug: Dabigatran etexilate
Test 2 (T2)	Experimental	Drug: Dabigatran etexilate + BI 1323495

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
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
Subjects genotyped as Uridine 5'-diphospho-Glucuronosyltransferase-2B17 (UGT2B17) extensive metabolisers, i.e. carrying at least one functional allele of UGT2B17 gene (*1/*1 or *1/*2)

Key exclusion criteria (27 listed)

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 (including positive or missing faecal occult blood test in Part 2)
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinTablet	Drug	Reference 1 (R1)
Rosuvastatin + BI 1323495Tablets	Drug	Test 1 (T1)
Dabigatran etexilateCapsule	Drug	Reference 2 (R2)
Dabigatran etexilate + BI 1323495Capsule and tablets	Drug	Test 2 (T2)

Primary outcome

Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax)
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
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 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax)
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.

2 secondary outcomes

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)
Time frame: Measured within 3 hours (h) before and up to 95h 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)
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.

Results and safety

Results posted to the registry on 23 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1323495 (T1)	7	7
Part 1: Rosuvastatin + BI 1323495 (T1) / Rosuvastatin (R1)	7	7
Part 2: Dabigatran (R2) / Dabigatran + BI 1323495 (T2)	7	7
Part 2: Dabigatran + BI 1323495 (T2) / Dabigatran (R2)	7	7

Primary outcome: Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.. Geometric least squares mean (Standard Error). Unit: Hours * nanogramm / milliliter

Measure	Rosuvastatin (Part 1, Reference 1) n = 12	Rosuvastatin + BI 1323495 (Part 1, Test 1) n = 14
Value	23.92 (NA)	25.20 (NA)

Rosuvastatin (Part 1, Reference 1) vs Rosuvastatin + BI 1323495 (Part 1, Test 1): Ratio of geometric means (T/R) %: 105.37 (90% CI 97.94 to 113.35), ANOVA

Population analysed: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS:All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Rosuvastatin:AUC0-∞ only calculated for 12 subjects, due for 2 subjects concentrations at last sampling point were higher than at preceding time point.

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

Measure	Rosuvastatin (Part 1, Reference 1) n = 14	Rosuvastatin + BI 1323495 (Part 1, Test 1) n = 14
Value	2.20 (NA)	2.52 (NA)

Rosuvastatin (Part 1, Reference 1) vs Rosuvastatin + BI 1323495 (Part 1, Test 1): Ratio of geometric means (T/R) %: 114.50 (90% CI 104.22 to 125.81), ANOVA

Population analysed: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

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

Measure	Dabigatran (Part 2, Reference 2) n = 14	Dabigatran + BI 1323495 (Part 2, Test 2) n = 14
Value	666.24 (NA)	720.76 (NA)

Dabigatran (Part 2, Reference 2) vs Dabigatran + BI 1323495 (Part 2, Test 2): Ratio of geometric means (T/R) %: 108.18 (90% CI 100.26 to 116.73), ANOVA

Population analysed: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

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

Measure	Dabigatran (Part 2, Reference 2) n = 14	Dabigatran + BI 1323495 (Part 2, Test 2) n = 14
Value	80.01 (NA)	87.12 (NA)

Dabigatran (Part 2, Reference 2) vs Dabigatran + BI 1323495 (Part 2, Test 2): Ratio of geometric means (T/R) %: 108.89 (90% CI 99.84 to 118.76), ANOVA

Population analysed: All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin (Part 1, Reference 1)	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14
Rosuvastatin + BI 1323495 (Part 1, Test 1)	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14
Dabigatran (Part 2, Reference 2)	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Dabigatran + BI 1323495 (Part 2, Test 2)	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: https://www.mystudywindow.com/msw/datasharing

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rosuvastatin, Rosuvastatin + BI 1323495 and Dabigatran etexilate in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04257032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.