Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function

NCT01111318 | Completed Phase 1 Results

• 2 other identifiers: 1245.132009-017202-36
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.

Conditions

Hepatic Insufficiency; Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve 0 to Infinity (AUC0-∞)

  Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration

• Maximum Measured Concentration (Cmax)

  Maximum measured concentration of empagliflozin (empa) in plasma. The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration

Secondary Outcomes (12)

• Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.

• Time From Dosing to Maximum Concentration (Tmax)

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.

• Terminal Rate Constant (λz)

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration

• Terminal Half-Life (t1/2)

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration

• Mean Residence Time (MRTpo)

  Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration

Study Arms (1)

BI 10773

EXPERIMENTAL

50 mg single dose

Drug: BI 10773

Interventions

BI 10773 DRUG

2 tablets BI 10773 25 mg single dose

BI 10773

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
• Healthy subjects (group 1)
• Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
• Relevant gastrointestinal tract surgery.
• Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
• History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure \< 100 or \> 160 mm Hg, diastolic blood pressure \< 60 or \> 100 mm Hg, pulse rate \< 50 or \> 100 1/min.
• Chronic or relevant acute infections.
• History of allergy/hypersensitivity.
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
• Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
• Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
• Inability to refrain from smoking when confined to the study site on trial days.
• Alcohol abuse, drug abuse.
• Veins unsuited for iv puncture on either arm.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1245.13.40001 Boehringer Ingelheim Investigational Site

Timișoara, Romania

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 27, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Last Updated: June 13, 2014
• Results First Posted: June 13, 2014

Record last verified: 2014-05

Locations

RO (1)