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Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Primary Purpose

Healthy Volunteers and Glaucoma Patients

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

MRZ-99030 eye drops 5mg/mL

MRZ-99030 eye drops 20mg/mL

Placebo to MRZ-99030 eye drops

About this trial

This is an interventional treatment trial for Healthy Volunteers and Glaucoma Patients

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For stage 1:

- Healthy volunteers

For stage 2:

- Glaucoma patients

Exclusion Criteria:

For stage 2:

- Any relevant eye disease other than glaucoma

Sites / Locations

Parexel International GmbH, Early Phase Clinical Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Healthy volunteers low dose

Healthy volunteers high dose

Glaucoma patients

Placebo

Arm Description

MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Placebo eye drops, 1-3 drops three times per day, duration: 16 days.

Outcomes

Primary Outcome Measures

Incidence of adverse events

Secondary Outcome Measures

Area under the curve (AUC)

Maximal plasma concentration (Cmax)

Full Information

NCT ID

NCT01714960

First Posted

October 24, 2012

Last Updated

January 28, 2014

Sponsor

Merz Pharmaceuticals GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01714960

Brief Title

Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Official Title

Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2). To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers and Glaucoma Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers low dose

Arm Type

Experimental

Arm Description

MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.

Arm Title

Healthy volunteers high dose

Arm Type

Experimental

Arm Description

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Arm Title

Glaucoma patients

Arm Type

Experimental

Arm Description

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo eye drops, 1-3 drops three times per day, duration: 16 days.

Intervention Type

Drug

Intervention Name(s)

MRZ-99030 eye drops 5mg/mL

Intervention Type

Drug

Intervention Name(s)

MRZ-99030 eye drops 20mg/mL

Intervention Type

Drug

Intervention Name(s)

Placebo to MRZ-99030 eye drops

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

Day 1 up to day 23

Secondary Outcome Measure Information:

Title

Area under the curve (AUC)

Time Frame

Day 1 to day 17

Title

Maximal plasma concentration (Cmax)

Time Frame

Day 1 to day 17

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For stage 1: - Healthy volunteers For stage 2: - Glaucoma patients Exclusion Criteria: For stage 2: - Any relevant eye disease other than glaucoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Expert

Organizational Affiliation

Merz Pharmaceuticals GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Parexel International GmbH, Early Phase Clinical Unit

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

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Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

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