Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers

NCT02183532 | Completed Phase 1

• 1 other identifier: 1218.58
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of 5 mg in Chinese healthy subjects

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state)

  up to day 19

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

  up to day 19

Secondary Outcomes (26)

• Cmax (Maximum measured concentration of the analyte in plasma) at different time points after single and multiple doses

  up to day 19

• tmax (Time from dosing to maximum measured concentration) at different time points after single and multiple doses

  up to day 19

• AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)

  up to day 7

• AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable analyte plasma concentration after single dose administration)

  up to day 7

• AUC0-24 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after single dose administration)

  up to 24 h after single dose administration

Study Arms (1)

BI 1356 BS

EXPERIMENTAL

Drug: BI 1356 BS

Interventions

BI 1356 BS DRUG

single dose

BI 1356 BS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female Chinese healthy volunteers who meet the criteria below:
• Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead Electrocardiogram (ECG), and laboratory test results
• Age ≥18 and Age ≤45 years
• Body weight ≥50 kg with BMI ≥19 and BMI ≤24 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good clinical Practice (GCP) and the local legislation

You may not qualify if:

• Persons who deviate from the norm, and who show clinical findings (Blood pressure (BP), Heart rate (HR), and ECG) on consultation
• Persons with any clinically significant complications
• Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immune, or hormonal disorders
• Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or neurological disorders
• Persons with a history of significant orthostatic hypotension, syncopal attacks, or blackouts
• Persons with chronic infection or severe acute infection
• Persons with a history of severe allergy/hypersensitivity (including allergies to drugs or inactive ingredients)
• Persons who will have received a drug with a long half-life (more than 24 hours) within the month before treatment in this study, within a period 10 times longer than the half-life of each drug, or during the study
• Persons who will have received a drug that may theoretically affect the study results based on the information obtained at the time of preparation of the protocol, within the 10 days before treatment or during the study (e.g inhibitors or inducers of Pgp or CYP 3A4)
• Persons who will have participated in another trial of an investigational drug within the 4 months before treatment or during the study
• Smokers (who smoke more than 10 cigarettes, or 3 cigars, or 3 pipes per day)
• Persons who cannot abstain from smoking throughout the study
• Persons who undoubtedly abuse alcohol
• Persons who abuse drugs
• Persons who donate blood of 100 mL or more within the 4 weeks before treatment

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Linagliptin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

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

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07