HealthyPhase 1NCT00879099
Interaction Study of Timolol Eye Drops and Paroxetine Capsules
A Phase 1 study testing Paroxetine and timolol maleate in people with Healthy, run by Santen Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Paroxetine and timolol maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2009to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- 18 - 40 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Helsinki, Department of Clinical Pharmacology
Helsinki, Biomedicum, 00014
About this study
Official title: The Effect of Paroxetine on the Plasma Levels of Timolol Using Ophthalmic 0.5% Timolol Eye Drops and 0.1% Timolol Eye Gel in Healthy Volunteers
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.
- Conditions
- Healthy
- Being tested
- Paroxetine, Placebo, timolol maleate
- Keywords
- Interaction, healthy volunteers, Interaction study for healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.
PlaceboDrug
Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.
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 maleateDrug
Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.
| Study group | Role | What they receive |
|---|---|---|
| Paroxetine | Active comparator | Not described Receives: Drug: Paroxetine |
| Gelatine capsule | Placebo comparator | Not described Receives: 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. Receives: 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. Receives: Drug: timolol maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janne Backman, MD, PhD, Principal investigator, Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879099
- Sponsor's protocol ID
- 73654
- Other IDs
- Eudra CT 2008-007324-26
- Status last verified
- Jul 2009
- First submitted
- 7 Apr 2009
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paroxetine on the Plasma Levels of Timolol Using Ophthalmic 0.5% Timolol Eye Drops and 0.1% Timolol Eye Gel in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00879099
- Acronym / sponsor ID
- 73654
- Conditions
- Healthy
- Keywords
- Interaction, healthy volunteers, Interaction study for healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Santen OyIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paroxetine | Active comparator | Drug: Paroxetine |
| Gelatine capsule | Placebo comparator | Drug: Placebo |
| Timolol 0.5 % eye drops | Experimental | Drug: timolol maleateThe plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes. |
| Timosan 0.1% eye gel | Experimental | Drug: timolol maleateThe plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- male
- 18 - 40 years of age
- be in good general health
- be willing to follow instructions
- provide a written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParoxetineParoxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days. | Drug | Paroxetine |
| PlaceboGelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days. | Drug | Gelatine capsule |
| timolol maleateOftan Timolol 0,5 % eye drop. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days. | Drug | Timolol 0.5 % eye drops |
| timolol maleateTimosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days. | Drug | Timosan 0.1% eye gel |
Primary outcome
The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Backman, MD, PhD principal investigator
Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paroxetine and timolol maleate in people with Healthy, run by Santen Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax). (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2010.