A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Intraocular pressure at Day -1, Days 1 & 14.
Study Overview
Brief Summary
This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males or females.
- •Non-smokers
- •Agree to remain in the clinic for the time defined in the protocol.
- •Normal ECG.
Exclusion Criteria
- •Any serious medical disorder or condition.
- •Any history of an endocrine disorder.
- •Any clinically significant laboratory abnormality.
- •History of psychiatric illness.
- •Any history of suicidal attempts or behavior.
- •Risk factors for precipitation of angle closure glaucoma or elevated IOP.
- •Inability to refrain from use of contact lenses during the study days, if correction is required.
- •Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
- •Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
Arms & Interventions
Treatment Group 1
Subjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks.
Intervention: WellbutrinXL (Drug)
Treatment Group 1
Subjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks.
Intervention: placebo (Drug)
Treatment Group 2
Subjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD.
Intervention: WellbutrinXL (Drug)
Treatment Group 2
Subjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD.
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Intraocular pressure at Day -1, Days 1 & 14.
Time Frame: at Day -1, Days 1 & 14.
Secondary Outcomes
- adverse events(each visit)
- lab tests,ECG,vital signs:(screening,followup)
- lab tests:(Days-2,13-14)
- ECG:(Day 14)
- vital signs:(Days-2,-1,1,14)
- Intraocular pressure,Pupil diameter, anterior chamber angle(Days-1,1&14)
- Wellbutrin XL plasma level(Days1,12-14)