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

NCT ID: NCT02177305

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31

Brief Summary

Safety and tolerability after ocular administration

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tiotropium dose group 1

0.02 mcg tiotropium solution

Group Type: EXPERIMENTAL

0.02 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Tiotropium dose group 2

0.04 mcg tiotropium solution

Group Type: EXPERIMENTAL

0.04 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Tiotropium dose group 3

0.08 mcg tiotropium solution

Group Type: EXPERIMENTAL

0.08 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Tiotropium dose group 4

0.16 mcg tiotropium solution

Group Type: EXPERIMENTAL

0.16 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Tiotropium dose group 5

0.28 mcg tiotropium solution

Group Type: EXPERIMENTAL

0.28 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Tiotropium dose group 6

0.40 mcg tiotropium solution

Group Type: EXPERIMENTAL

0.40 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

Interventions

0.02 mcg tiotropium solution

Intervention Type: DRUG

0.04 mcg tiotropium solution

Intervention Type: DRUG

0.08 mcg tiotropium solution

Intervention Type: DRUG

0.16 mcg tiotropium solution

Intervention Type: DRUG

0.28 mcg tiotropium solution

Intervention Type: DRUG

0.40 mcg tiotropium solution

Intervention Type: DRUG

Placebo solution

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

205.138

Identifier Type: -

Identifier Source: org_study_id