Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01309139
First received: March 1, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT).

The secondary objectives are:

to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively


Condition Intervention Phase
Healthy
Drug: Tiotropium
Drug: BI 54903
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomised, Two-way Crossover Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Via Respimat® B Versus the Combination of the Monoproducts of Tiotropium Via Respimat® A and BI 54903 Via Respimat® B in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss) [ Time Frame: on several time points until day 22 ] [ Designated as safety issue: No ]
  • Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss) [ Time Frame: on several time points until day 22 ] [ Designated as safety issue: No ]
  • AUCτ,ss for Tiotropium [ Time Frame: on several time points until day 22 ] [ Designated as safety issue: No ]
  • Cmax,ss for Tiotropium [ Time Frame: on several time points until day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCτ,ss for BI 54903 [ Time Frame: on several time points until day 22 ] [ Designated as safety issue: No ]
  • Cmax,ss for BI 54903 [ Time Frame: on several time points until day 22 ] [ Designated as safety issue: No ]
  • Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium [ Time Frame: on Day 1 and 21 ] [ Designated as safety issue: No ]
  • Change in physical examination [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Change in vital signs [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Change in 12-lead electrocardiogram [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Change in clinical laboratory tests [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by the investigator [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A: Tiotropium medium dose
Oral inhalation daily for 21 days
Drug: Tiotropium
Medium dose of oral inhalation
Experimental: Treatment A: BI 54903 high dose
Oral inhalation daily for 21 days
Drug: BI 54903
Medium dose of oral inhalation
Experimental: Treatment B: Tiotropium medium dose
Oral inhalation daily for 21 days
Drug: Tiotropium
Medium dose of oral inhalation
Experimental: Treatment C: BI 54903 high dose
Oral inhalation daily for 21 days
Drug: BI 54903
Medium dose of oral inhalation

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests.
  2. Age 21 to 50 years.

Exclusion criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. History or evidence of relevant psychiatric disorders or neurological disorders
  5. History or evidence of relevant autonomic dysfunction (orthostatic hypotension, fainting spells or blackouts)
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  8. Intake of any prescription drugs or over-the-counter (over the counter (OTC)) medication (vitamins, herbal supplements, dietary supplements) 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
  9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  10. Smoker (more than 10 cigarettes daily)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309139

Locations
Germany
1298.2.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01309139     History of Changes
Other Study ID Numbers: 1298.2, 2010-023780-18
Study First Received: March 1, 2011
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014