Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pioglitazone; Drug: BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT02276365

1245.17

Details and patient eligibility

About

The objective of the study was to investigate whether there is a drug-drug interaction between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs were given in combination compared with BI 10773 and pioglitazone given alone.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males according to the following criteria:

  • Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests

• Age 18 to 50 years (incl.)

• BMI 18.5 to 29.9 kg/m2 (incl.)

• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion criteria

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 30 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• ALT (Alanine transaminase) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of trial site
• Galactose or lactose intolerance, galactose or glucose malabsorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sequence ABC

Experimental group

Description:

1. Treatment A: 50 mg BI 10773 once daily from day 1 to 5 2. Treatment B: 50 mg BI 10773 and 45 mg pioglitazone once daily from day 1 to 7 3. Treatment C: 45 mg pioglitazone once daily from day 1 to 7 after 7 days wash-out

Treatment:

Drug: Pioglitazone

Drug: BI 10773

Sequence CAB

Experimental group

Description:

1. Treatment C: 45 mg pioglitazone once daily from day 1 to 7 2. Treatment A: 50 mg BI 10773 once daily from day 1 to 5 after 7 days wash-out 3. Treatment B: 50 mg BI 10773 and 45 mg pioglitazone once daily from day 1 to 7

Treatment:

Drug: Pioglitazone

Drug: BI 10773