SchizophreniaPhase 1MNK112891NCT01090440
Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Subjects
A Phase 1 study testing GSK1144814 in people with Schizophrenia, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- GSK1144814
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2009to 9 Oct 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if the Investigator and the and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age.
- A female subject is eligible to participate if she is of:
- Non childbearing potential defined as pre menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] greater than 40 mIU/mL and oestradiol less than 40 pg/mL [less than 140 pmol/L] is confirmatory).
- Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Male subjects must agree to use one of the contraception methods alloed by the protocol. This criterion must be followed from the first dosing day until 3 months after the last dose.
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- Body weight greater than or equal to 50 kg and BMI within the range 19 to 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Demonstrates no evidence of mental impairment or co-morbid psychiatric disorders
Who cannot join
- History or presence of clinically significant cardiac arrhythmias, or other clinically significant cardiac disease.
- QTcB or QTcF greater than 450 msec.
- Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
- The subject has a positive pre study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre study hepatitis B surface antigen (HBsAg) or positive hepatitis C virus (HCV) antibody test result within 3 months of Screening.
- A positive test result for antibodies to human immunodeficiency virus (HIV) 1/2.
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- Significant renal abnormality (from medical history or as indicated by laboratory investigations). Additionally subjects with idiopathic haematuria or proteinuria or conditions such as benign orthostatic proteinuria and benign familial haematuria should be excluded from the study.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine containing products within 6 months prior to Screening.
- Subjects, who in the investigator's judgement, pose a significant homicidal risk or have ever been homicidal.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of regular alcohol consumption within 6 months of the study defined as the following Australian guidelines:
- An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to 270ml of full strength beer, 470ml of light beer, 30ml of spirits and 100ml of wine.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Consumption of Seville oranges (including marmalade) and/or grapefruit and/or Chinese grapefruit (pomelo) and/or grapefruit hybrids and/or exotic citrus fruits and/or their fruit juices from 7 days prior to the first dosing day.
- Consumption of red wine from 7 days prior to the first dosing day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomised, Three-way Cross-over Study to Evaluate the Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Male and Female Subjects
GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant.
This study will be an open label, randomised, three-way cross-over study to evaluate the safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female subjects.
Read the detailed description
GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant.
This study will be an open label, randomised, three-way cross-over study to evaluate the safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female (non-child bearing potential) subjects.
The study will consist of a Screening visit (up to 30 days before the first dosing session), three dosing sessions each separated by a maximum of at least 6 days washout, and a Follow up visit (7 to 14 days after the last dose of study medication). Each subject's participation in the study will be approximately 12 weeks Sixteen subjects will be enrolled to provide a minimum number of 12 evaluable subjects. The doses to be administered will be 100 mg and 200mg in the fasted state, and 100mg following a high fat breakfast.
Subjects will be admitted to the unit on Day 1 of each dosing session and will remain in the unit until 48 hours after dosing. Pharmacokinetic samples will be taken for up to 72 hours post dose. The duration of both in patient stay and PK sampling may be subject to change depending on emerging safety and PK results. Dosing will be in the morning approximately the same time for all sessions.
The objectives of the study are to evaluate the pharmacokinetics, safety and tolerability of GSK1144814. Pharmacokinetic objectives are to evaluate the pharmacokinetic parameters of single oral doses of GSK1144814 administered as a tablet formulation in healthy male and female subjects and to evaluate the effect of a high-fat meal on the pharmacokinetics of GSK1144814 tablet following single dose administration of GSK1144814 to healthy male and female subjects.
The safety and tolerability objectives are to evaluate the safety and tolerability of single oral doses of GSK1144814 tablet formulation in fed and fasted states.
- Conditions
- Schizophrenia
- Being tested
- GSK1144814
- Keywords
- schizophrenia, GSK1144814, effect of food, healthy subjects, depressive disorder, pharmacokinetics
- Medical subject headings
- Schizophrenia, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1144814Drug
This study is an open label, randomised, three-way cross-over study to evaluate the pharmacokinetics, effect of food, safety and tolerability of a new tablet formulation of GSK1144814 in healthy male and female (non-child bearing potential) subjects. Sixteen subjects will be enrolled to provide a minimum number of 12 evaluable subjects. The doses to be administered will be 100 mg and 200mg in the fasted state, and 100mg following a high fat breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Three-way cross- over | Experimental | Three regimens will be administered in this study: A: GSK1144814 Tablet (100mg) Fasted State; B: GSK1144814 Tablet (200mg) Fasted State and C: GSK 1144814 Tablet (100mg) Fed State (FDA high fat breakfast). Receives: Drug: GSK1144814 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: tlag, Cmax, tmax, AUC(0-24), AUC(0 t), t½ and AUC(0 to infinity).
Measured: 2 months
Secondary outcomes (1)
Safety and tolerability: AE monitoring, vital signs (blood pressure, heart rate, body temperature, electrocardiograms (ECGs) (12 lead and Holter), clinical laboratory assessments (standard laboratory parameters).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study start1 Sep 2009
- Primary completion9 Oct 2009
- Study completion9 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090440
- Sponsor's protocol ID
- 112891
- Acronym
- MNK112891
- Status last verified
- Jun 2017
- First submitted
- 4 Mar 2010
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Three-way Cross-over Study to Evaluate the Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01090440
- Acronym / sponsor ID
- MNK112891 / 112891
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, GSK1144814, effect of food, healthy subjects, depressive disorder, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 9 Oct 2009 (actual)
- Study completion
- 9 Oct 2009 (actual)
- First posted
- 22 Mar 2010 (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.
GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant.
This study will be an open label, randomised, three-way cross-over study to evaluate the safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female subjects.
Detailed description
GSK1144814 is a potent, insurmountable antagonist at human neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors with the potential to treat multiple symptom domains of schizophrenia and be an efficacious antidepressant.
This study will be an open label, randomised, three-way cross-over study to evaluate the safety, tolerability and pharmacokinetics of a new tablet formulation of GSK1144814 and to evaluate the effect of food on single oral doses of GSK1144814 in healthy male and female (non-child bearing potential) subjects.
The study will consist of a Screening visit (up to 30 days before the first dosing session), three dosing sessions each separated by a maximum of at least 6 days washout, and a Follow up visit (7 to 14 days after the last dose of study medication). Each subject's participation in the study will be approximately 12 weeks Sixteen subjects will be enrolled to provide a minimum number of 12 evaluable subjects. The doses to be administered will be 100 mg and 200mg in the fasted state, and 100mg following a high fat breakfast.
Subjects will be admitted to the unit on Day 1 of each dosing session and will remain in the unit until 48 hours after dosing. Pharmacokinetic samples will be taken for up to 72 hours post dose. The duration of both in patient stay and PK sampling may be subject to change depending on emerging safety and PK results. Dosing will be in the morning approximately the same time for all sessions.
The objectives of the study are to evaluate the pharmacokinetics, safety and tolerability of GSK1144814. Pharmacokinetic objectives are to evaluate the pharmacokinetic parameters of single oral doses of GSK1144814 administered as a tablet formulation in healthy male and female subjects and to evaluate the effect of a high-fat meal on the pharmacokinetics of GSK1144814 tablet following single dose administration of GSK1144814 to healthy male and female subjects.
The safety and tolerability objectives are to evaluate the safety and tolerability of single oral doses of GSK1144814 tablet formulation in fed and fasted states.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-way cross- over | Experimental | Drug: GSK1144814Three regimens will be administered in this study: A: GSK1144814 Tablet (100mg) Fasted State; B: GSK1144814 Tablet (200mg) Fasted State and C: GSK 1144814 Tablet (100mg) Fed State (FDA high fat breakfast). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if the Investigator and the and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age.
- A female subject is eligible to participate if she is of:
- Non childbearing potential defined as pre menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] greater than 40 mIU/mL and oestradiol less than 40 pg/mL [less than 140 pmol/L] is confirmatory).
- Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Key exclusion criteria (19 listed)
- History or presence of clinically significant cardiac arrhythmias, or other clinically significant cardiac disease.
- QTcB or QTcF greater than 450 msec.
- Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
- The subject has a positive pre study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre study hepatitis B surface antigen (HBsAg) or positive hepatitis C virus (HCV) antibody test result within 3 months of Screening.
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 |
|---|---|---|
| GSK1144814This study is an open label, randomised, three-way cross-over study to evaluate the pharmacokinetics, effect of food, safety and tolerability of a new tablet formulation of GSK1144814 in healthy male and female (non-child bearing potential) subjects. Sixteen subjects will be enrolled to provide a minimum number of 12 evaluable subjects. The doses to be administered will be 100 mg and 200mg in the fasted state, and 100mg following a high fat breakfast. | Drug | Three-way cross- over |
Primary outcome
Pharmacokinetics: tlag, Cmax, tmax, AUC(0-24), AUC(0 t), t½ and AUC(0 to infinity).
Time frame: 2 months
1 secondary outcome
Safety and tolerability: AE monitoring, vital signs (blood pressure, heart rate, body temperature, electrocardiograms (ECGs) (12 lead and Holter), clinical laboratory assessments (standard laboratory parameters).
Time frame: 2 months
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 22 Jun 2017.
- Results for study 112891 can be found on the GSK Clinical Study Register.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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GSK1144814 in people with Schizophrenia, run by GlaxoSmithKline at 1 site in Australia.
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 9 inclusion and 19 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 22 Jun 2017. 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 Australia. 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?
Pharmacokinetics: tlag, Cmax, tmax, AUC(0-24), AUC(0 t), t½ and AUC(0 to infinity). (time frame: 2 months). 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 22 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.