Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers

NCT02172235 | Completed Phase 1

• 1 other identifier: 1245.50
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs

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)

  Before each dosing, up to 10 days

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

  Before each dosing, up to 10 days

Secondary Outcomes (21)

• C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose)

  Before each dosing, up to 10 days

• λz (terminal elimination rate constant of the analyte in plasma)

  Before each dosing, up to 10 days

• t½ (terminal half-life of the analyte in plasma)

  Before each dosing, up to 10 days

• tmax (time from last dosing to maximum measured concentration of the analyte in plasma)

  Before each dosing, up to 10 days

• MRTpo (mean residence time of the analyte in the body at steady state after oral administration)

  Before each dosing, up to 10 days

Study Arms (6)

Pioglitazone

ACTIVE COMPARATOR

Drug: Pioglitazone

Pioglitazone + BI 10773 low

EXPERIMENTAL

Drug: Pioglitazone; Drug: BI 10773 - low dose

Pioglitazone + BI 10773 medium

EXPERIMENTAL

Drug: Pioglitazone; Drug: BI 10773 - medium dose

Pioglitazone + BI 10773 high

EXPERIMENTAL

Drug: Pioglitazone; Drug: BI 10773 - high dose

Pioglitazone low + BI 10773 medium

EXPERIMENTAL

Drug: Pioglitazone - low dose; Drug: BI 10773 - medium dose

Pioglitazone + BI 10773 1 hour after Pioglitazone

EXPERIMENTAL

Drug: Pioglitazone; Drug: BI 10773 - medium dose

Interventions

Pioglitazone DRUG

Pioglitazone; Pioglitazone + BI 10773 1 hour after Pioglitazone; Pioglitazone + BI 10773 high; Pioglitazone + BI 10773 low; Pioglitazone + BI 10773 medium

Pioglitazone - low dose DRUG

Pioglitazone low + BI 10773 medium

BI 10773 - low dose DRUG

Pioglitazone + BI 10773 low

BI 10773 - medium dose DRUG

Pioglitazone + BI 10773 1 hour after Pioglitazone; Pioglitazone + BI 10773 medium; Pioglitazone low + BI 10773 medium

BI 10773 - high dose DRUG

Pioglitazone + BI 10773 high

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the following criteria:
• medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests
• Age 18 to 55 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 Good Clinical Practise (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination including blood pressure (BP), pulse rate (PR) and electrocardiogram (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

Pioglitazone; empagliflozin

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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Last Updated: June 24, 2014

Record last verified: 2014-06