Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects

NCT01195675 | Completed Phase 1 Results

• 2 other identifiers: 1245.162010-018609-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing

  Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg. Note, the treatment means presented are actually adjusted means.

  60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose

• Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing

  Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg. Note, the treatment means presented are actually adjusted means.

  60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose

Secondary Outcomes (5)

• Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing

  60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

• Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing

  60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

• Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing

  60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose

• Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings

  60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

• Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings

  60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

Other Outcomes (3)

• Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing.

  60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

• Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings.

  60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

• Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator

  Drug administration until beginning of next sequence/end of trial, up to 48 days

Study Arms (3)

BI 10773

EXPERIMENTAL

single oral (high and low) dose per subject

Drug: BI 10773 (low); Drug: BI 10773 (high)

Placebo

PLACEBO COMPARATOR

2 single oral doses per subject

Drug: BI 10773 Placebo

Moxifloxacin

ACTIVE COMPARATOR

single oral dose per subject

Drug: Moxifloxacin

Interventions

BI 10773 (low) DRUG

single oral dose

BI 10773

Moxifloxacin DRUG

single oral dose

Moxifloxacin

BI 10773 Placebo DRUG

2 times single dose

Placebo

BI 10773 (high) DRUG

single oral dose

BI 10773

Eligibility Criteria

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

You may qualify if:

• healthy female and male subjects

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1245.16.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

• Ring A, Brand T, Macha S, Breithaupt-Groegler K, Simons G, Walter B, Woerle HJ, Broedl UC. The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study. Cardiovasc Diabetol. 2013 Apr 24;12:70. doi: 10.1186/1475-2840-12-70.

  PMID: 23617452 DERIVED

MeSH Terms

Interventions

empagliflozin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-07

Locations

DE (1)