Healthy WomenPhase 1NCT02112903
Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
A Phase 1 study testing Encapsulated vortioxetine IR tablet, 20 mg, Vortioxetine MR capsule 20 mg (pH 5.5) and Vortioxetine MR capsule 20 mg (pH 6.0) in people with Healthy Women, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Encapsulated vortioxetine IR tablet, 20 mg, Vortioxetine MR capsule 20 mg (pH 5.5) and Vortioxetine MR capsule 20 mg (pH 6.0)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Sep 2014
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of >18.5 and <30.0 kg/m2.
- Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.
- Other protocol-defined Inclusion and Exclusion Criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.
- Conditions
- Healthy Women
- Being tested
- Encapsulated vortioxetine IR tablet, 20 mg, Vortioxetine MR capsule 20 mg (pH 5.5), Vortioxetine MR capsule 20 mg (pH 6.0), Vortioxetine MR capsule 20 mg (pH 7.0)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated vortioxetine IR tablet, 20 mgDrug
Vortioxetine MR capsule 20 mg (pH 5.5)Drug
Vortioxetine MR capsule 20 mg (pH 6.0)Drug
Vortioxetine MR capsule 20 mg (pH 7.0)Drug
| Study group | Role | What they receive |
|---|---|---|
| Encapsulated vortioxetine IR tablet, 20 mg | Experimental | Single oral dose Receives: Drug: Encapsulated vortioxetine IR tablet, 20 mg |
| Vortioxetine MR capsule 20 mg (pH 5.5) | Experimental | Single oral dose Receives: Drug: Vortioxetine MR capsule 20 mg (pH 5.5) |
| Vortioxetine MR capsule 20 mg (pH 6.0) | Experimental | Single oral dose Receives: Drug: Vortioxetine MR capsule 20 mg (pH 6.0) |
| Vortioxetine MR capsule 20 mg (pH 7.0) | Experimental | Single oral dose Receives: Drug: Vortioxetine MR capsule 20 mg (pH 7.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale
Measured: Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale
Measured: Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale
Measured: Up to 24 hours post-dose in each treatment period
Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)
Measured: Up to 72 hours post-dose in each treatment period
Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Measured: Up to 72 hours postdose
Maximum observed concentration (Cmax) of vortioxetine
Measured: Up to 72 hours postdose
Nominal time corresponding to the occurrence of Cmax (tmax)
Measured: Up to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112903
- Sponsor's protocol ID
- 15947A
- Other IDs
- 2014-000121-20, 2014
- Status last verified
- Nov 2014
- First submitted
- 10 Apr 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
- ClinicalTrials.gov ID
- NCT02112903
- Acronym / sponsor ID
- 15947A
- Conditions
- Healthy Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- First posted
- 14 Apr 2014 (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 evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Encapsulated vortioxetine IR tablet, 20 mg | Experimental | Drug: Encapsulated vortioxetine IR tablet, 20 mgSingle oral dose |
| Vortioxetine MR capsule 20 mg (pH 5.5) | Experimental | Drug: Vortioxetine MR capsule 20 mg (pH 5.5)Single oral dose |
| Vortioxetine MR capsule 20 mg (pH 6.0) | Experimental | Drug: Vortioxetine MR capsule 20 mg (pH 6.0)Single oral dose |
| Vortioxetine MR capsule 20 mg (pH 7.0) | Experimental | Drug: Vortioxetine MR capsule 20 mg (pH 7.0)Single oral dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of >18.5 and <30.0 kg/m2.
- Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.
- Other protocol-defined Inclusion and Exclusion Criteria may apply.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Encapsulated vortioxetine IR tablet, 20 mg | Drug | Encapsulated vortioxetine IR tablet, 20 mg |
| Vortioxetine MR capsule 20 mg (pH 5.5) | Drug | Vortioxetine MR capsule 20 mg (pH 5.5) |
| Vortioxetine MR capsule 20 mg (pH 6.0) | Drug | Vortioxetine MR capsule 20 mg (pH 6.0) |
| Vortioxetine MR capsule 20 mg (pH 7.0) | Drug | Vortioxetine MR capsule 20 mg (pH 7.0) |
Primary outcome
Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale
Time frame: Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale
Time frame: Up to 24 hours post-dose in each treatment period
Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale
Time frame: Up to 24 hours post-dose in each treatment period
Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)
Time frame: Up to 72 hours post-dose in each treatment period
Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Time frame: Up to 72 hours postdose
Maximum observed concentration (Cmax) of vortioxetine
Time frame: Up to 72 hours postdose
Nominal time corresponding to the occurrence of Cmax (tmax)
Time frame: Up to 72 hours postdose
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 13 Nov 2014.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
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 Encapsulated vortioxetine IR tablet, 20 mg, Vortioxetine MR capsule 20 mg (pH 5.5) and Vortioxetine MR capsule 20 mg (pH 6.0) in people with Healthy Women, run by H. Lundbeck A/S at 1 site in United Kingdom.
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 3 inclusion and 0 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 13 Nov 2014. 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 United Kingdom. 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. 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?
Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale (time frame: Up to 24 hours post-dose in each treatment period). The study lists 7 primary outcomes in all. 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 13 Nov 2014; AzTrials last refreshed its copy on 29 Oct 2026.