Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers

NCT02276365 | Completed Phase 1

• 1 other identifier: 1245.17
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 10 days

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 10 days

Secondary Outcomes (17)

• Abnormal findings in physical examination

  Baseline and up to 10 days after last study drug administration

• Changes from baseline in vital signs (Blood pressure, pulse rate)

  Baseline and up to 10 days after last study drug administration

• Changes from baseline in 12-lead ECG (electrocardiogram)

  Baseline and up to 10 days after last study drug administration

• Changes in clinical laboratory tests

  Baseline and up to 10 days after last study drug administration

• Incidence of adverse events

  up to 35 days

Study Arms (2)

Sequence ABC

EXPERIMENTAL

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

Drug: BI 10773; Drug: Pioglitazone

Sequence CAB

EXPERIMENTAL

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

Drug: BI 10773; Drug: Pioglitazone

Interventions

BI 10773 DRUG

Sequence ABC; Sequence CAB

Pioglitazone DRUG

Sequence ABC; Sequence CAB

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

empagliflozin; Pioglitazone

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 28, 2014
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: October 28, 2014

Record last verified: 2014-05