Transporter Cocktail Mutual Interaction

NCT ID: NCT02854527

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-22
• Study Completion Date: 2016-11-19

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R1 (Reference 1) Digoxin

1 tablet (0.25 mg) digoxin as single dose

Group Type: EXPERIMENTAL

Digoxin

Intervention Type: DRUG

single dose

R2 Furosemide

0.1 mL (1 mg) furosemide oral solution as single dose

Group Type: EXPERIMENTAL

Furosemide

Intervention Type: DRUG

single dose

R3 Metformin hydrochloride

0.1 mL (10 mg) metformin oral solution as single dose

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

single dose

R4 Rosuvastatin

1 tablet (10 mg) rosuvastatin as single dose

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

single dose

T (Test)

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')

Group Type: EXPERIMENTAL

Digoxin

Intervention Type: DRUG

0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point)

Furosemide

Intervention Type: DRUG

1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point)

Metformin hydrochloride

Intervention Type: DRUG

10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point)

Rosuvastatin

Intervention Type: DRUG

10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)

Interventions

Digoxin

single dose

Intervention Type: DRUG

Furosemide

single dose

Intervention Type: DRUG

Metformin

single dose

Intervention Type: DRUG

Rosuvastatin

single dose

Intervention Type: DRUG

Digoxin

0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point)

Intervention Type: DRUG

Furosemide

1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point)

Intervention Type: DRUG

Metformin hydrochloride

10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point)

Intervention Type: DRUG

Rosuvastatin

10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Countries

Germany

Other Identifiers

2016-001893-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

352.2096

Identifier Type: -

Identifier Source: org_study_id