Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference

Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product

The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tiotropium

Detailed Description

Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy Volunteer
• Willing and able to give informed consent
• Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
• Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

• Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
• Any presence or history of a clinically significant allergy including any adverse reaction to study drug
• History of drug or alcohol abuse within the past 2 years
• Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
• Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
• Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
• If female, nursing, lactating or pregnant
• Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product 1 Tiotropium; 4 inhalations	Drug: Tiotropium; Other Names: Spiriva
Experimental: Test Product 2 Tiotropium; 4 inhalations	Drug: Tiotropium; Other Names: Spiriva
Experimental: Test Product 3 Tiotropium; 4 inhalations	Drug: Tiotropium; Other Names: Spiriva
Active Comparator: Reference Tiotropium; 2 inhalations	Drug: Tiotropium; Other Names: Spiriva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	maximum plasma concentration	48 hours

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Study Chair: Victoria Sessions, PhD, 3M

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: inhalation; anticholinergic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: CSP-07-000030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: results will be shared through publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No