HealthyPhase 1NCT01299805

Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults

A Phase 1 study testing Vortioxetine in people with Healthy, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy men. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Vortioxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Jul 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Weighs at least 50 kg and has a body mass index between 19.0 and 32.0 kg/m^2, inclusive at Screening.
Males who are nonsterilized and sexually active with a female partner of childbearing potential must agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 6 weeks after last dose of study medication. The acceptable method of contraception is defined as one that has no higher than a 1% failure rate.

Who cannot join

Received any investigational compound within 45 days prior to Check-in (Day -2).
Received Lu AA21004 in previous clinical study or as therapeutic agent.
History of or uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, central nervous system, hepatic hematopoietic disease, renal metabolic, gastrointestinal, or endocrine disease, serious allergy, asthma, hypoxemia, hypertension, seizures, allergic skin rash or other abnormality, which may impact the ability of the participant to participate or potentially confound study results.
Participant has 1 or more of the following:
Any current psychiatric disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR).
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.

Show all 33Show fewer

Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder.
Has a known hypersensitivity to any component of the formulation of Lu AA21004.
Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -2).
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 4 or more units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
The participant intends to impregnate or donate sperm during the course of this study or for 6 weeks after last dose.
Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (e.g., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis; frequent (more than once per week) occurrence of heartburn, or any intra-abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy).
Has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to Day 1.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody at Screening or a known history of human immunodeficiency virus infection.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -2) or is unwilling to abstain from these products for the duration of the study.
Cotinine test is positive at Screening or Check-in (Day 2).
Has poor peripheral venous access.
Has donated or lost 450 mL or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
Has a Screening or Check-in (Day -2) abnormal (clinically significant) electrocardiogram (ECG). Entry of any patient with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator.
Has abnormal Screening or Day -2 laboratory values that suggest a clinically significant underlying disease or with the following lab abnormalities: alanine aminotransferase and/or aspartate aminotransferase >1.5 times the upper limit of normal.
Has had cerebrospinal fluid (CSF) collection performed within 30 days prior to Check-in (Day -2).
Has taken any selective serotonin reuptake inhibitor (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors, antipsychotics, tricyclic antidepressants, or mood stabilizers within the last year prior to Screening.
Has a known hypersensitivity to the anesthetic or its derivatives used during CSF collection, or any medication used to prepare the area of lumbar puncture.
Has significant vertebral deformities (scoliosis or kyphosis) which, in the opinion of the investigator, may interfere with lumbar puncture procedure.
Has a history of clinically significant back pain and/or injury.
Has local infection at the puncture site.
Has a history of significant bleeding or coagulation disorder and/or low platelet levels (<130x10^9/L) or increased international normalized ratio (INR) (>1.3) at Screening.
Answers positive to any suicidal ideation and/or suicidal behavior questions during administration of the Columbia-Suicide Severity Rating Scale.
Has an orthostatic blood pressure drop of ≥20 mm Hg (based on the drop between supine and standing [3 minutes] systolic blood pressure) at Screening or Check-in (Day -2).
Has abnormal Screening or Day -2 vital signs: resting systolic blood pressure ≤90 or ≥140 mm Hg or a resting diastolic blood pressure ≤50 or ≥90 mm Hg in supine position; resting pulse or heart rate (as read on ECG) <45 bpm or >100 bpm. No more than 2 repeat measurements.
Exercises extensively in his normal life (e.g., marathon running, triathlon, physical sports at a contest level etc).

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Glendale, California

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Effects of Oral Administration of Lu AA21004 20 mg on the Concentrations of Selected Neurotransmitters in Healthy Male Subjects

Read the detailed description

This study will look at an investigational medicine called vortioxetine to see how the drug affects the body and how the body handles the drug.

The study enrolled 17 patients. Participants were randomly assigned at a 2:1 ratio to one of the following two treatment groups-which remained undisclosed to both the participant and study doctor during the study (unless there was an urgent medical need):

Vortioxetine 20 mg
Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This single-center trial was conducted in the United States. The overall time to participate in this study was approximately 7 weeks. Participants made 2 visits to the clinic, including 18 days confinement to the clinic, and were contacted by telephone 1 day and 27 days after leaving confinement for a follow-up assessment.

Conditions: Healthy
Being tested: Vortioxetine, Placebo
Keywords: Drug Therapy, pharmacodynamic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VortioxetineDrug
Also called Lu AA21004, Brintellix
Encapsulated tablet
PlaceboDrug
Vortioxetine placebo-matching capsules.

Study groups in NCT01299805
Study group	Role	What they receive
Vortioxetine	Experimental	Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days. Receives: Drug: Vortioxetine
Placebo	Placebo comparator	Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Maximum Concentration of 5-HT in Plasma
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Time to Maximum Concentration of 5-HT in Plasma
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Maximum Concentration of 5-HT in Cerobrospinal Fluid
The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma
Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.
Measured: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Maximum Concentration of 5-HIAA in Plasma
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1
Measured: Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Time to Maximum Concentration of 5-HIAA in Plasma
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.
Measured: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Measured: Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jul 2011

First posted18 Feb 2011 (estimated)
Study startMar 2011
Primary completionJun 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by TakedaThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01299805
Sponsor's protocol ID: LuAA21004_124
Other IDs: U1111-1119-1680
Status last verified: Oct 2013
First submitted: 17 Feb 2011
Last updated: 13 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Effects of Oral Administration of Lu AA21004 20 mg on the Concentrations of Selected Neurotransmitters in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01299805
Acronym / sponsor ID: LuAA21004_124
Conditions: Healthy
Keywords: Drug Therapy, pharmacodynamic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jun 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 18 Feb 2011 (estimated)
Results: Posted 13 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will look at an investigational medicine called vortioxetine to see how the drug affects the body and how the body handles the drug.

Vortioxetine 20 mg
Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Vortioxetine	Experimental	Drug: VortioxetineVortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
Placebo	Placebo comparator	Drug: PlaceboVortioxetine placebo-matching capsules, orally, once daily for up to 14 days.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Weighs at least 50 kg and has a body mass index between 19.0 and 32.0 kg/m^2, inclusive at Screening.
Males who are nonsterilized and sexually active with a female partner of childbearing potential must agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 6 weeks after last dose of study medication. The acceptable method of contraception is defined as one that has no higher than a 1% failure rate.

Key exclusion criteria (33 listed)

Received any investigational compound within 45 days prior to Check-in (Day -2).
Received Lu AA21004 in previous clinical study or as therapeutic agent.
History of or uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, central nervous system, hepatic hematopoietic disease, renal metabolic, gastrointestinal, or endocrine disease, serious allergy, asthma, hypoxemia, hypertension, seizures, allergic skin rash or other abnormality, which may impact the ability of the participant to participate or potentially confound study results.
Participant has 1 or more of the following:
Has a known hypersensitivity to any component of the formulation of Lu AA21004.

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
VortioxetineAlso: Lu AA21004, BrintellixEncapsulated tablet	Drug	Vortioxetine
PlaceboVortioxetine placebo-matching capsules.	Drug	Placebo

Primary outcome

Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma
Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Maximum Concentration of 5-HT in Plasma
Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time to Maximum Concentration of 5-HT in Plasma
Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Maximum Concentration of 5-HT in Cerobrospinal Fluid
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid
Time frame: Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma
Time frame: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.
Maximum Concentration of 5-HIAA in Plasma
Time frame: Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1
Time to Maximum Concentration of 5-HIAA in Plasma
Time frame: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
Time frame: Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).

Results and safety

Results posted to the registry on 13 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vortioxetine	12	10
Placebo	5	5

Primary outcome: Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma

Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.. Mean (Standard Deviation). Unit: pg*hr/mL

Measure	Vortioxetine n = 12	Placebo n = 5
Day -1 (n=10, 4)	4183024 (1362135)	3854399 (1728230)
Day 1 (n=6, 4)	4224058 (2028835)	3912292 (2083773)
Day 14 (n=9, 5)	1718863 (530633)	3858350 (2212719)

Population analysed: The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. "n" indicates the number of patients with available data at each time point.

Primary outcome: Maximum Concentration of 5-HT in Plasma

Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.. Mean (Standard Deviation). Unit: pg/mL

Measure	Vortioxetine n = 12	Placebo n = 5
Day -1 (n=10, 4)	273800 (111197)	231500 (98083.3)
Day 1 (n=6, 4)	247667 (136695)	251250 (63615.4)
Day 14 (n=9, 5)	94233.3 (40258.4)	242200 (115103)

Primary outcome: Time to Maximum Concentration of 5-HT in Plasma

Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.. Mean (Standard Deviation). Unit: hours

Measure	Vortioxetine n = 12	Placebo n = 5
Day -1 (n=10, 4)	12.65 (9.409)	7.26 (7.984)
Day 1 (n=6, 4)	4.86 (7.253)	14.42 (11.146)
Day 14 (n=9, 5)	9.11 (10.080)	8.40 (6.986)

Primary outcome: Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid

Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.. Mean (Standard Deviation). Unit: pg*hr/mL

Measure	Vortioxetine n = 12	Placebo n = 5
Day -1 (n=11, 5)	987.71 (1898.943)	509.77 (199.658)
Day 1 (n=11, 5)	627.78 (164.679)	497.40 (302.720)
Day 14 (n=9, 5)	1165.73 (290.389)	444.88 (24.908)

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vortioxetine	0 of 12 (0%)	11 of 12 (91.7%)	Not reported
Placebo	0 of 5 (0%)	4 of 5 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director, Clinical Science study director

Takeda

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 Vortioxetine in people with Healthy, run by Takeda at 1 site in United States.

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 2 inclusion and 33 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 Dec 2013. 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 States. 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?

Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma (time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01299805.

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 Dec 2013.