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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 0.28 mcg tiotropium solution; Drug: 0.16 mcg tiotropium solution; Drug: 0.40 mcg tiotropium solution; Drug: Placebo solution; Drug: 0.02 mcg tiotropium solution; Drug: 0.04 mcg tiotropium solution; Drug: 0.08 mcg tiotropium solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177305

205.138

Details and patient eligibility

About

Safety and tolerability after ocular administration

Enrollment: 48 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 6 patient groups

Tiotropium dose group 1

Experimental group

Description:

0.02 mcg tiotropium solution

Treatment:

Drug: Placebo solution

Drug: 0.02 mcg tiotropium solution

Tiotropium dose group 2

Experimental group

Description:

0.04 mcg tiotropium solution

Treatment:

Drug: Placebo solution

Drug: 0.04 mcg tiotropium solution

Tiotropium dose group 3

Experimental group

Description:

0.08 mcg tiotropium solution

Treatment:

Drug: Placebo solution

Drug: 0.08 mcg tiotropium solution

Tiotropium dose group 4

Experimental group

Description:

0.16 mcg tiotropium solution

Treatment:

Drug: Placebo solution

Drug: 0.16 mcg tiotropium solution

Tiotropium dose group 5

Experimental group

Description:

0.28 mcg tiotropium solution

Treatment:

Drug: 0.28 mcg tiotropium solution

Drug: Placebo solution

Tiotropium dose group 6

Experimental group

Description:

0.40 mcg tiotropium solution

Treatment:

Drug: Placebo solution

Drug: 0.40 mcg tiotropium solution