HealthyPhase 1NCT02854527

Transporter Cocktail Mutual Interaction

A Phase 1 study testing Digoxin, Furosemide and Metformin 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

Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin, furosemide, metformin, and rosuvastatin when given all together as a cocktail 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?: Digoxin, Furosemide and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteGermany
Study dates: 22 Aug 2016to 19 Nov 2016
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 investigator's assessment, 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 (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and local legislation

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged 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 50 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 judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 25Show 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 medication or its excipients, sulphonamides, or cardiac glycosides)
Use of drugs within 30 days prior to administration of trial medication that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation (corrected Q-T interval)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
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 30 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
In addition, the following trial-specific exclusion criteria apply:
Hypokalemia, hypomagnesemia, or hypercalcemia
PQ ( (time between the onset of the P wave (atrial activity) and the QRS complex (ventricular activity)) interval greater than 220 ms in the ECG at screening
Myopathy
Hereditary galactose or fructose intolerance, lactase deficiency, or glucose-galactose malabsorption

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: Investigation of Mutual Pharmacokinetic Interactions of Digoxin, Furosemide, Metformin, and Rosuvastatin Given All Together as a Probe Cocktail for Key Drug Transporters (an Open-label, Randomised, Single-dose, Five-way Crossover Study)

Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin, furosemide, metformin, and rosuvastatin when given all together as a cocktail

Conditions: Healthy
Being tested: Digoxin, Furosemide, Metformin, Rosuvastatin, Metformin hydrochloride

What participants receive

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

DigoxinDrug
single dose
FurosemideDrug
single dose
MetforminDrug
single dose
RosuvastatinDrug
single dose
DigoxinDrug
0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point)
FurosemideDrug
1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point)
Metformin hydrochlorideDrug
10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point)
RosuvastatinDrug
10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)

Study groups in NCT02854527
Study group	Role	What they receive
R1 (Reference 1) Digoxin	Experimental	1 tablet (0.25 mg) digoxin as single dose Receives: Drug: Digoxin
R2 Furosemide	Experimental	0.1 mL (1 mg) furosemide oral solution as single dose Receives: Drug: Furosemide
R3 Metformin hydrochloride	Experimental	0.1 mL (10 mg) metformin oral solution as single dose Receives: Drug: Metformin
R4 Rosuvastatin	Experimental	1 tablet (10 mg) rosuvastatin as single dose Receives: Drug: Rosuvastatin
T (Test)	Experimental	1 tablet (0.25 mg) digoxin, 0.1 mL (1 mg) furosemide oral solution, 0.1 mL (10 mg) metformin oral solution, and 1 tablet (10 mg) rosuvastatin, all together as a single dose ('cocktail') Receives: Drug: Digoxin; Drug: Furosemide; Drug: Metformin hydrochloride; Drug: Rosuvastatin

What is being measured

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

Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. CI - confidence interval, gMean - geometric mean.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Maximum Concentration of Digoxin (Cmax)
This outcome measure presents the maximum measured concentration of digoxin in plasma (Cmax). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of furosemide in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
Maximum Concentration of Furosemide (Cmax)
This outcome measure presents the maximum measured concentration of furosemide in plasma (Cmax). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
Area Under the Curve of Metformin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration
Maximum Concentration of Metformin (Cmax)
This outcome measure presents the maximum measured concentration of metformin in plasma (Cmax). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration
Area Under the Curve of Rosuvastatin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Maximum Concentration of Rosuvastatin (Cmax)
This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration

Secondary outcomes (4)

Area Under the Curve of Digoxin From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Area Under the Curve of Furosemide From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of furosemide in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
Area Under the Curve of Metformin From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration
Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.
Measured: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration

Timeline

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

22 Aug 201619 Nov 2016

First posted3 Aug 2016 (estimated)
Study start22 Aug 2016
Primary completion11 Nov 2016
Study completion19 Nov 2016

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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02854527
Sponsor's protocol ID: 352.2096
Other IDs: 2016-001893-14, 2016
Status last verified: Oct 2023
First submitted: 1 Aug 2016
Last updated: 7 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Mutual Pharmacokinetic Interactions of Digoxin, Furosemide, Metformin, and Rosuvastatin Given All Together as a Probe Cocktail for Key Drug Transporters (an Open-label, Randomised, Single-dose, Five-way Crossover Study)
ClinicalTrials.gov ID: NCT02854527
Acronym / sponsor ID: 352.2096
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 22 Aug 2016 (actual)
Primary completion: 11 Nov 2016 (actual)
Study completion: 19 Nov 2016 (actual)
First posted: 3 Aug 2016 (estimated)
Results: Posted 6 Aug 2018

Clinical summary

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

Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin, furosemide, metformin, and rosuvastatin when given all together as a cocktail

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
R1 (Reference 1) Digoxin	Experimental	Drug: Digoxin1 tablet (0.25 mg) digoxin as single dose
R2 Furosemide	Experimental	Drug: Furosemide0.1 mL (1 mg) furosemide oral solution as single dose
R3 Metformin hydrochloride	Experimental	Drug: Metformin0.1 mL (10 mg) metformin oral solution as single dose
R4 Rosuvastatin	Experimental	Drug: Rosuvastatin1 tablet (10 mg) rosuvastatin as single dose
T (Test)	Experimental	Drug: Digoxin, Drug: Furosemide, Drug: Metformin hydrochloride, Drug: Rosuvastatin1 tablet (0.25 mg) digoxin, 0.1 mL (1 mg) furosemide oral solution, 0.1 mL (10 mg) metformin oral solution, and 1 tablet (10 mg) rosuvastatin, all together as a single dose ('cocktail')

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male subjects according to the investigator's assessment, 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 (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and local legislation

Key exclusion criteria (25 listed)

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged 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 50 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 judged 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
Digoxinsingle dose	Drug	R1 (Reference 1) Digoxin
Furosemidesingle dose	Drug	R2 Furosemide
Metforminsingle dose	Drug	R3 Metformin hydrochloride
Rosuvastatinsingle dose	Drug	R4 Rosuvastatin
Digoxin0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point)	Drug	T (Test)
Furosemide1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point)	Drug	T (Test)
Metformin hydrochloride10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point)	Drug	T (Test)
Rosuvastatin10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)	Drug	T (Test)

Primary outcome

Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. CI - confidence interval, gMean - geometric mean.
Maximum Concentration of Digoxin (Cmax)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
This outcome measure presents the maximum measured concentration of digoxin in plasma (Cmax). Standard error presented is actually geometric standard error.
Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
Area under the concentration-time curve of furosemide in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.
Maximum Concentration of Furosemide (Cmax)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
This outcome measure presents the maximum measured concentration of furosemide in plasma (Cmax). Standard error presented is actually geometric standard error.
Area Under the Curve of Metformin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.
Maximum Concentration of Metformin (Cmax)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration
This outcome measure presents the maximum measured concentration of metformin in plasma (Cmax). Standard error presented is actually geometric standard error.
Area Under the Curve of Rosuvastatin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.
Maximum Concentration of Rosuvastatin (Cmax)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax). Standard error presented is actually geometric standard error.

4 secondary outcomes

Area Under the Curve of Digoxin From 0 Extrapolated to Infinity (AUC 0-∞)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
Area Under the Curve of Furosemide From 0 Extrapolated to Infinity (AUC 0-∞)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
Area Under the Curve of Metformin From 0 Extrapolated to Infinity (AUC 0-∞)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration
Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC 0-∞)
Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration

Results and safety

Results posted to the registry on 6 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABECD (R1->R2->T->R3->R4)	3	3
AEBDC (R1->T->R2->R4->R3)	3	3
BACED (R2->R1->R3->T->R4)	3	3
BCADE (R2->R3->R1->R4->T)	3	2
CBDAE (R3->R2->R4->R1->T)	3	2
CDBEA (R3->R4->R2->T->R1)	3	3
DCEBA (R4->R3->T->R2->R1)	3	3
DECAB (R4->T->R3->R1->R2)	3	3
EADBC (T->R1->R4->R2->R3)	3	3
EDACB (T->R4->R1->R3->R2)	3	3

Primary outcome: Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz)

Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration. Geometric mean (Standard Error). Unit: nanomole hour per liter (nmol·h/L)

Measure	Test Cocktail (T) n = 28	Digoxin (R1) n = 28
Value	11.549 (1.053)	11.981 (1.053)

Test Cocktail (T) vs Digoxin (R1): Adjusted Geometric mean ratio (T/R1) (%): 96.39 (90% CI 88.22 to 105.33), ANOVA

Population analysed: The Pharmacokinetic (PK) analysis set (PKS) included all randomized subjects who were documented to have taken at least 1 dose of study drug and who have provided at least 1 primary or secondary PK endpoint that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.

Primary outcome: Maximum Concentration of Digoxin (Cmax)

Measure	Test Cocktail (T) n = 28	Digoxin (R1) n = 28
Value	1.262 (1.047)	1.355 (1.047)

Test Cocktail (T) vs Digoxin (R1): Adjusted Geometric mean ratio (T/R1) (%): 93.17 (90% CI 83.49 to 103.97), ANOVA

Population analysed: PKS

Primary outcome: Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz)

Time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration. Geometric mean (Standard Error). Unit: nmol·h/L

Measure	Test Cocktail (T) n = 28	Furosemide (R2) n = 30
Value	163.614 (1.039)	159.434 (1.038)

Test Cocktail (T) vs Furosemide (R2): Adjusted Geometric mean ratio (T/R2) (%): 102.62 (90% CI 93.82 to 112.25), ANOVA

Population analysed: PKS

Primary outcome: Maximum Concentration of Furosemide (Cmax)

Measure	Test Cocktail (T) n = 28	Furosemide (R2) n = 30
Value	86.275 (1.046)	82.990 (1.044)

Test Cocktail (T) vs Furosemide (R2): Adjusted Geometric mean ratio (T/R2) (%): 103.96 (90% CI 93.60 to 115.46), ANOVA

Population analysed: PKS

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) occurring up to 192 hours after intake of trial drug administration in each treatment period were assigned to treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digoxin (R1)	1 of 28 (3.6%)	0 of 28 (0%)	Not reported
Furosemide (R2)	0 of 30 (0%)	0 of 30 (0%)	Not reported
Metformin Hydrochloride (R3)	0 of 29 (0%)	1 of 29 (3.4%)	Not reported
Rosuvastatin (R4)	0 of 29 (0%)	1 of 29 (3.4%)	Not reported
Test Cocktail (T)	0 of 28 (0%)	3 of 28 (10.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Synopsis LinkLink 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Digoxin, Furosemide and Metformin 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 4 inclusion and 25 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 7 Nov 2023. 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 6 Aug 2018). 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?

Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz) (time frame: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration). The study lists 8 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 NCT02854527.

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 7 Nov 2023.