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

NCT02177305 | Completed Phase 1

• 1 other identifier: 205.138
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety and tolerability after ocular administration

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (6)

Tiotropium dose group 1

EXPERIMENTAL

0.02 mcg tiotropium solution

Drug: 0.02 mcg tiotropium solution; Drug: Placebo solution

Tiotropium dose group 2

EXPERIMENTAL

0.04 mcg tiotropium solution

Drug: 0.04 mcg tiotropium solution; Drug: Placebo solution

Tiotropium dose group 3

EXPERIMENTAL

0.08 mcg tiotropium solution

Drug: 0.08 mcg tiotropium solution; Drug: Placebo solution

Tiotropium dose group 4

EXPERIMENTAL

0.16 mcg tiotropium solution

Drug: 0.16 mcg tiotropium solution; Drug: Placebo solution

Tiotropium dose group 5

EXPERIMENTAL

0.28 mcg tiotropium solution

Drug: 0.28 mcg tiotropium solution; Drug: Placebo solution

Tiotropium dose group 6

EXPERIMENTAL

0.40 mcg tiotropium solution

Drug: 0.40 mcg tiotropium solution; Drug: Placebo solution

Interventions

0.02 mcg tiotropium solution DRUG

Tiotropium dose group 1

0.04 mcg tiotropium solution DRUG

Tiotropium dose group 2

0.08 mcg tiotropium solution DRUG

Tiotropium dose group 3

0.16 mcg tiotropium solution DRUG

Tiotropium dose group 4

0.28 mcg tiotropium solution DRUG

Tiotropium dose group 5

0.40 mcg tiotropium solution DRUG

Tiotropium dose group 6

Placebo solution DRUG

Tiotropium dose group 1; Tiotropium dose group 2; Tiotropium dose group 3; Tiotropium dose group 4; Tiotropium dose group 5; Tiotropium dose group 6

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 27, 2014
• Study Start: October 1, 1998
• Primary Completion: December 1, 1998
• Last Updated: June 27, 2014

Record last verified: 2014-06