Tiotropium in Combination With Concomitant Cimetidine or Ranitidine in Healthy Male and Female Subjects

NCT02172417 | Completed Phase 1

• 1 other identifier: 205.222
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax of plasma levels of tiotropium after dosing

  up to 8 hours after i.v. treatment

• Area under the curve (AUC) 0-4h of the plasma levels of tiotropium after dosing

  0 - 4 hours after i.v. treatment

• Urinary excretion 0-4h after dosing (Ae0-4h)

  0 - 4 hours after i.v. treatment

• Renal clearance of tiotropium (CLR)

  pre-dose, 0-4 h, 4-8 h, 8-12 h, 12-24 , 24-28 h, 38-72 h and 72-96 h after i.v. treatment

Secondary Outcomes (7)

• AUC 0-8h of plasma levels of tiotropium after dosing

  0-8 hours after treatment

• Urinary excretion 0-96h after dosing (Ae0-96h)

  0-96 hours after treatment

• Occurrence of Adverse Events

  up to 4 - 8 days after last i.v. treatment

• Changes from baseline in Laboratory Tests

  Baseline, 4 - 8 days after last i.v. treatment

• Changes in 12-lead electrocardiogram (ECG)

  up to 24 h after i.v. treatment

Study Arms (2)

Cimetidine + Tiotropium followed by Tiotropium

EXPERIMENTAL

Drug: Cimetidine + Tiotropium; Drug: Tiotropium

Ranitidine + Tiotropium followed by Tiotropium

EXPERIMENTAL

Drug: Ranitidine + Tiotropium; Drug: Tiotropium

Interventions

Cimetidine + Tiotropium DRUG

Cimetidine + Tiotropium followed by Tiotropium

Ranitidine + Tiotropium DRUG

Ranitidine + Tiotropium followed by Tiotropium

Tiotropium DRUG

Cimetidine + Tiotropium followed by Tiotropium; Ranitidine + Tiotropium followed by Tiotropium

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females
• Age range from 50 to 65 years
• Within 20% of their normal weight (Broca index)

You may not qualify if:

• Any finding of the medical examination (including blood pressure, puls rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Use of any drugs which might influence the results of the trial within four weeks prior to administration or during the trial, among these all non-selective β-blockers, cromolyn sodium, nedocromil sodium, oral β-adrenergics or long-acting β-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT® (ipratropium) by oral inhalation or ATROVENT® Nasal Spray
• Participation in another study with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 40 g/day)
• Drug abuse
• Blood donation (≥ 100 ml) within four weeks prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the reference range of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Cimetidine; Tiotropium Bromide; Ranitidine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Furans

Study Design

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

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: July 1, 2000
• Primary Completion: November 1, 2000
• Last Updated: June 24, 2014

Record last verified: 2014-06