Clinical trial NCT02177305: Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 48
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and tolerability after ocular administration


Eligibility criteria: 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

Primary outcomes:
measure: Change in pupil diameter
timeFrame: baseline, after 24 hours
measure: Change in pupillary reflex
timeFrame: baseline, after 24 hours
measure: Change in intraocular pressure
timeFrame: baseline, after 24 hours
measure: Change in accommodation
timeFrame: baseline, after 24 hours
Secondary outcomes:
measure: Change from baseline in blood pressure
timeFrame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
measure: Change from baseline in pulse rate
timeFrame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
measure: Change in 12-lead ECG
timeFrame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
measure: Changes from baseline in standard laboratory examinations
timeFrame: Baseline and within 8 days after treatment day
measure: Occurrence of Adverse Events
timeFrame: until 8 days after treatment day
Other outcomes:
Locations:
Study officials:
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