BI 1744 CL in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function

NCT02172118 | Completed Phase 1

• 1 other identifier: 1222.35
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the influence of severe renal impairment on the pharmacokinetics (PK), safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by inhalation with the Respimat® Inhaler)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-4 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 4 hours after dosing)

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

• Cmax (maximum concentration of the analyte in plasma)

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

Secondary Outcomes (14)

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

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

• AUC (area under the concentration-time curve of the analyte in plasma at different time points)

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

• %AUCtz-∞ (percentage of area under the concentration-time curve obtained by extrapolation)

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

• λz (terminal rate constant in plasma)

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  before and at 0:05, 0:10, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00 hours following drug administration

Study Arms (2)

severely renally impaired patients

EXPERIMENTAL

Drug: BI 1774 CL

healthy volunteers

EXPERIMENTAL

Drug: BI 1774 CL

Interventions

BI 1774 CL DRUG

healthy volunteers; severely renally impaired patients

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects:
• Healthy male and female subjects determined by results of screening with a creatinine clearance \>80 mL/min (Treatment Group 2)
• Age 21 - 75 years
• Body Mass Index (BMI) \>=18.5 and \<=32 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
• Renally impaired subjects:
• Renally impaired male or female subjects (Treatment Group 1) determined by results of screening with the following creatinine clearance as estimated according to Cockroft-Gault: Creatinine clearance \<30 mL/min (Treatment Group 1, Renal Function Group 4)
• Age 21 - 75 years
• BMI \>=18.5 and \<=34 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Healthy subjects who meet any of the following criteria will not be entered into this trial:
• Any finding of the medical examination (including blood pressure (BP) \[\>140 mmHg systolic and or \>95 mmHg diastolic\], 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
• Relevant gastrointestinal tract surgery (except appendectomy, herniotomy)
• Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections (e.g. including Hepatitis B and C and HIV)
• History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
• 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
• Participation in another trial with an investigational drug within one month after previous single dose administration or two months after previous multiple dose administration prior to administration or during the trial
• 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 (more than 40 g/day in males, more than 20 g/day in females)
• Drug abuse, in the investigator's judgement upon review of the patient's history and urine screening for abused substances

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06