HealthyPhase 1ZoloftNCT02651623
Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
A Phase 1 study testing Sertraline and Moxifloxacin in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Belgium.
Trial summary
The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals relative to time-matched placebo in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sertraline and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Sep 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Risk factors for QT prolongation or torsades de pointes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Center Randomized, Three-way Crossover, Double-blinded, Placebo- And Moxifloxacin-controlled Thorough Qt (Tqt) Study To Determine The Effects Of Sertraline (Zoloft (Registered)) On The Cardiac Repolarization In Healthy Subjects
The purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals relative to time-matched placebo in healthy subjects
Read the detailed description
Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and tolerability of sertraline in healthy subjects.
- Conditions
- Healthy
- Being tested
- Sertraline, Moxifloxacin, Drug - Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called active drug
Multiple doses of sertraline for 14 days
MoxifloxacinDrug
Also called Positive control
A single dose of 400 mg Moxifloxacin
Drug - PlaceboDrug
Also called Placebo control
Placebo administered for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | Maximum dose of 400 mg/day (200 mg BID given at approximately 12 hours apart) sertraline, dose titrated from a starting single dose (QD) of 50 mg in the morning on Day 1 followed by BID doses administered on Days 2 through 14 (Day 14 morning dose only) will be administered Receives: Drug: Sertraline |
| Moxifloxacin | Active comparator | 400 mg single dose of moxifloxacin (Avelox®) administered on Day 14 Receives: Drug: Moxifloxacin |
| Drug - Placebo | Placebo comparator | placebo - placebo administered on Days 1 through 14 Receives: Drug: Drug - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postdose QTcF (Fridericia's correction) intervals
Measured: 0 to 72 hours
Secondary outcomes (2)
Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability)
Measured: Through study completion, an average of 3 months
Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations
Measured: 0 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651623
- Sponsor's protocol ID
- A0501104
- Other IDs
- 2015-000103-47, TQT, 2015
- Acronym
- Zoloft
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2015
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center Randomized, Three-way Crossover, Double-blinded, Placebo- And Moxifloxacin-controlled Thorough Qt (Tqt) Study To Determine The Effects Of Sertraline (Zoloft (Registered)) On The Cardiac Repolarization In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02651623
- Acronym / sponsor ID
- Zoloft / A0501104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Jan 2016 (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 purpose of this study is to demonstrate a lack of effect of sertraline on QTc intervals relative to time-matched placebo in healthy subjects
Detailed description
Evaluate multiple doses of 400 mg per day of sertraline on QTc, and evaluate the safety and tolerability of sertraline in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: SertralineMaximum dose of 400 mg/day (200 mg BID given at approximately 12 hours apart) sertraline, dose titrated from a starting single dose (QD) of 50 mg in the morning on Day 1 followed by BID doses administered on Days 2 through 14 (Day 14 morning dose only) will be administered |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin400 mg single dose of moxifloxacin (Avelox®) administered on Day 14 |
| Drug - Placebo | Placebo comparator | Drug: Drug - Placeboplacebo - placebo administered on Days 1 through 14 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Risk factors for QT prolongation or torsades de pointes
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 |
|---|---|---|
| SertralineAlso: active drugMultiple doses of sertraline for 14 days | Drug | Sertraline |
| MoxifloxacinAlso: Positive controlA single dose of 400 mg Moxifloxacin | Drug | Moxifloxacin |
| Drug - PlaceboAlso: Placebo controlPlacebo administered for 14 days | Drug | Drug - Placebo |
Primary outcome
Postdose QTcF (Fridericia's correction) intervals
Time frame: 0 to 72 hours
2 secondary outcomes
Averse events, vital signs, physical examinations and abnormal laboratory for safety assessments (safety and tolerability)
Time frame: Through study completion, an average of 3 months
Relationship between QTc prolongation and measured sertraline/metabolite plasma concentrations
Time frame: 0 to 72 hours
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 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Sertraline and Moxifloxacin in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Belgium.
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 1 inclusion and 2 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 27 Jan 2021. 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 Belgium. 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?
Postdose QTcF (Fridericia's correction) intervals (time frame: 0 to 72 hours). 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 27 Jan 2021.