Bioavailability of BI 10773 and Sitagliptin in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 10773; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02172196

1245.27

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers according to the following criteria:

  • Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, 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 deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• 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 within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
• Participation in another trial with an investigational drug within two months prior to first study drug administration
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (average consumption of more than 30 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to the start of study)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of trial site
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
• A history of additional risk factors for TdP (Torsades de pointes) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Treatment sequence ABC

Experimental group

Description:

1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5 3. Treatment C: Sitagliptin once daily from day 1 to 5

Treatment:

Drug: Sitagliptin

Drug: BI 10773

Treatment sequence CAB

Experimental group

Description:

1. Treatment C: Sitagliptin once daily from day 1 to 5 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5

Treatment:

Drug: Sitagliptin

Drug: BI 10773