NCT00879099

Brief Summary

The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma levels of timolol and its main metabolites after topical application of ophthalmic timolol products. This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy male volunteers aged 18 - 40 years will be enrolled. Placebo or paroxetine will be given for three days after which 1 drop of timolol product will be administered once in both eyes. The duration of the paroxetine or placebo treatment period will be 3 days. There will be four different treatment periods. A washout between the study periods will be at least 4 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 28, 2010

Status Verified

July 1, 2009

Enrollment Period

9 months

First QC Date

April 7, 2009

Last Update Submit

January 27, 2010

Conditions

Healthy

Keywords

Interactionhealthy volunteersInteraction study for healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).

    1 day

Study Arms (4)

Paroxetine

ACTIVE COMPARATOR
Drug: Paroxetine

Gelatine capsule

PLACEBO COMPARATOR
Drug: Placebo

Timolol 0.5 % eye drops

EXPERIMENTAL

The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.

Drug: timolol maleate

Timosan 0.1% eye gel

EXPERIMENTAL

The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.

Drug: timolol maleate

Interventions

ParoxetineDRUG

Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.

Paroxetine
PlaceboDRUG

Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.

Gelatine capsule
timolol maleateDRUG

Oftan Timolol 0,5 % eye drop. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.

Timolol 0.5 % eye drops

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • years of age
  • be in good general health
  • be willing to follow instructions
  • provide a written informed consent
  • have a BMI of 18.5 - 26
  • have systolic blood pressure at least 105 mmHg
  • have haemoglobin at least 135 g/l.

You may not qualify if:

  • known hypersensitivity to timolol, paroxetine or any component of the study medications
  • any contraindications to timolol treatment including asthma and obstructive lung disease
  • any contraindications to paroxetine treatment
  • have heart rate 50/min or less in rest
  • any regular medication
  • allergy requiring antihistamine or ocular or nasal treatment
  • clinically significant abnormalities (from normal limits) in laboratory values: basic blood count, creatinine, ALAT, AFOS, gamma-GT, K, Na
  • clinically significant EKG abnormalities assessed by the investigator
  • blood donation within the last 60 days (the required time period between two donations for men given by RedCross Finland).
  • participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki, Department of Clinical Pharmacology

Helsinki, Biomedicum, 00014, Finland

Location

MeSH Terms

Interventions

ParoxetineTimolol

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesMorpholinesOxazines

Study Officials

  • Janne Backman, MD, PhD

    Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 28, 2010

Record last verified: 2009-07

Locations

FI(1)