Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products

• ClinicalTrials.gov Identifier: NCT02676297
• Recruitment Status: Completed
• First Posted: February 8, 2016
• Last Update Posted: July 14, 2016
• Sponsor: 3M
• Collaborator: Quotient Clinical
• Information provided by (Responsible Party): 3M

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: tiotropium	Phase 1

Detailed Description:

Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product
• Study Start Date: January 2016
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test product A; tiotropium	Drug: tiotropium; four inhalations; Other Name: Spiriva Respimat
Experimental: Test product B; tiotropium	Drug: tiotropium; four inhalations; Other Name: Spiriva Respimat
Active Comparator: reference product; tiotropium	Drug: tiotropium; four inhalations; Other Name: Spiriva Respimat

Outcome Measures

Primary Outcome Measures :

1. peak plasma concentration [ Time Frame: 8 hours ]
   measured by noncompartmental analysis

Secondary Outcome Measures :

1. adverse events [ Time Frame: 8 hours ]
   reported adverse events

Other Outcome Measures:

1. area under the plasma concentration vs. time curve [ Time Frame: 8 hours ]
   measured by the trapezoidal rule

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United Kingdom

Quotient Clinical Ltd

Ruddington, Nottingham, United Kingdom, NG11 6JS

Sponsors and Collaborators

3M

Quotient Clinical

Investigators

• Principal Investigator: Pui Leung, MD; Quotient Clinical

More Information

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT02676297
• Other Study ID Numbers: CSP-07-000027; 2015-004145-10 ( EudraCT Number )
• First Posted: February 8, 2016
• Last Update Posted: July 14, 2016
• Last Verified: July 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: will share summary data

Keywords provided by 3M:

inhalation; anticholinergic

Additional relevant MeSH terms:

Tiotropium Bromide; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Parasympatholytics; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action