Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers

A Single Increasing Dose Tolerance Study After Ocular Administration of Tiotropium (Single Doses: 0.02 - 0.4 mcg) in Healthy Male Volunteers (Randomised, Placebo-controlled, Double-blind, Parallel Groups).

Safety and tolerability after ocular administration

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 0.02 mcg tiotropium solution; Drug: Placebo solution; Drug: 0.04 mcg tiotropium solution; Drug: 0.08 mcg tiotropium solution; Drug: 0.16 mcg tiotropium solution; Drug: 0.28 mcg tiotropium solution; Drug: 0.40 mcg tiotropium solution

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males
• Age range from 21 to 50 years
• Within ± 20% of normal weight (Broca-Index)
• Written informed consent given

Exclusion Criteria:

• Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
• Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections
• Volunteers with history of allergy/ hypersensitivity (including drug allergy)
• Volunteers with known eye diseases (incl. glaucoma), with hyperopia (> 3 diopters) or with contact lenses
• Volunteers with intraocular pressure > 22 mmHg
• Volunteers with predisposition to narrow-angle glaucoma
• Volunteers with disturbed micturition
• Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
• Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study
• Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
• Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
• Volunteers who are not able to refrain from smoking on study day
• Volunteers who drink more than 40 g of alcohol per day
• Volunteers who are dependent on drugs
• Volunteers who have donated blood (≥ 100 ml) within the last four weeks
• Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium dose group 1; 0.02 mcg tiotropium solution	Drug: 0.02 mcg tiotropium solution; Drug: Placebo solution
Experimental: Tiotropium dose group 2; 0.04 mcg tiotropium solution	Drug: Placebo solution; Drug: 0.04 mcg tiotropium solution
Experimental: Tiotropium dose group 3; 0.08 mcg tiotropium solution	Drug: Placebo solution; Drug: 0.08 mcg tiotropium solution
Experimental: Tiotropium dose group 4; 0.16 mcg tiotropium solution	Drug: Placebo solution; Drug: 0.16 mcg tiotropium solution
Experimental: Tiotropium dose group 5; 0.28 mcg tiotropium solution	Drug: Placebo solution; Drug: 0.28 mcg tiotropium solution
Experimental: Tiotropium dose group 6; 0.40 mcg tiotropium solution	Drug: Placebo solution; Drug: 0.40 mcg tiotropium solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pupil diameter	baseline, after 24 hours
Change in pupillary reflex	baseline, after 24 hours
Change in intraocular pressure	baseline, after 24 hours
Change in accommodation	baseline, after 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in blood pressure	on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change from baseline in pulse rate	on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change in 12-lead ECG	on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Changes from baseline in standard laboratory examinations	Baseline and within 8 days after treatment day
Occurrence of Adverse Events	until 8 days after treatment day

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 1998
• Primary Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• 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; Pharmaceutical Solutions; Tiotropium Bromide
• Other Study ID Numbers: 205.138