Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: 0.28 mcg tiotropium solutionDrug: 0.40 mcg tiotropium solutionDrug: 0.02 mcg tiotropium solutionDrug: 0.08 mcg tiotropium solutionDrug: 0.16 mcg tiotropium solutionDrug: 0.04 mcg tiotropium solutionDrug: Placebo solution
- Registration Number
- NCT02177305
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Safety and tolerability after ocular administration
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tiotropium dose group 5 0.28 mcg tiotropium solution 0.28 mcg tiotropium solution Tiotropium dose group 5 Placebo solution 0.28 mcg tiotropium solution Tiotropium dose group 6 0.40 mcg tiotropium solution 0.40 mcg tiotropium solution Tiotropium dose group 6 Placebo solution 0.40 mcg tiotropium solution Tiotropium dose group 1 0.02 mcg tiotropium solution 0.02 mcg tiotropium solution Tiotropium dose group 3 0.08 mcg tiotropium solution 0.08 mcg tiotropium solution Tiotropium dose group 3 Placebo solution 0.08 mcg tiotropium solution Tiotropium dose group 4 0.16 mcg tiotropium solution 0.16 mcg tiotropium solution Tiotropium dose group 4 Placebo solution 0.16 mcg tiotropium solution Tiotropium dose group 2 0.04 mcg tiotropium solution 0.04 mcg tiotropium solution Tiotropium dose group 2 Placebo solution 0.04 mcg tiotropium solution Tiotropium dose group 1 Placebo solution 0.02 mcg tiotropium solution
- Primary Outcome Measures
Name Time Method Change in intraocular pressure baseline, after 24 hours Change in pupil diameter baseline, after 24 hours Change in pupillary reflex baseline, after 24 hours Change in accommodation baseline, after 24 hours
- Secondary Outcome Measures
Name Time Method 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 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