Depressive DisorderPhase 1NCT00728208
GSK372475 PK Study in Healthy Volunteers
A Phase 1 study testing GSK372475 in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo for 28 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- GSK372475
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jul 2008to 29 Dec 2008
- 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 years and older
- 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 and psychiatric history (including family history), full physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 45 years of age (young healthy population) and >65 years old (elderly population).
- 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
- Child-bearing potential and agrees to use of specific contraception methods. Use of oral contraception is permitted.
- BMI within the range 19 - 29 kg/m2 (inclusive).
Show all 9Show fewer
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- Able to swallow and retain oral medication
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular or other heart disease, glaucoma, diabetes, hepatic, neurologic (e.g. including but not limited to seizures, stroke, cerebrovascular disease or other brain conditions), or allergic disease (except for untreated, asymptomatic, seasonal allergies at time of dosing).
- Psychiatric illness currently or within the past year, or any lifetime history of bipolar disorder, major depressive disorder, anxiety disorder, schizophrenia or other psychotic disorder, or substance abuse or dependence (except past history of nicotine abuse/dependence).
- Subjects who, in the investigator's judgment, pose a suicidal or homicidal risk, or any subject with a history of suicidal or homicidal attempts or behaviour.
- 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 or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).
Show all 21Show fewer
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as:
- 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 a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- 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: 60 days i.e. 5 half-lives.
- 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 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.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Administration of a monoamine oxidase inhibitor (MAOI) within 30 days prior to Study Day 1, or anticipated use within 12 weeks following the last dose of study drug.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of grapefruit juice or grapefruit or cruciferous vegetables (e.g. broccoli, Brussels sprouts, cabbage, cauliflower, chard, kale, mustard greens, rutabagas and turnips) and charbroiled foods within 7 days prior to first dose of study medication until follow-up.
- Controlled or uncontrolled hypertension, or systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening or prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Single-blind, Randomised, Parallel Group, 28-day Repeat Dose Study to Investigate the Tolerability, Safety and Steady State Pharmacokinetics of GSK372475 in Healthy Young and Elderly, Male and Female Subjects
This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo for 28 days.
- Conditions
- Depressive Disorder
- Being tested
- GSK372475
- Keywords
- Young, Elderly, Randomised, GSK372475
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK372475Drug
1.5mg for 28 days
| Study group | Role | What they receive |
|---|---|---|
| GSK372475 | Experimental | Drug Receives: Drug: GSK372475 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro.
Measured: pre-dose to 24 hours post dose
Secondary outcomes (1)
Safety and tolerability endpoints, including adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory tests.
Measured: from dosing to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study start28 Jul 2008
- Primary completion29 Dec 2008
- Study completion29 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 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
- NCT00728208
- Sponsor's protocol ID
- 105467
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2008
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single-blind, Randomised, Parallel Group, 28-day Repeat Dose Study to Investigate the Tolerability, Safety and Steady State Pharmacokinetics of GSK372475 in Healthy Young and Elderly, Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00728208
- Acronym / sponsor ID
- 105467
- Conditions
- Depressive Disorder
- Keywords
- Young, Elderly, Randomised, GSK372475
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2008 (actual)
- Primary completion
- 29 Dec 2008 (actual)
- Study completion
- 29 Dec 2008 (actual)
- First posted
- 5 Aug 2008 (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.
This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK372475 | Experimental | Drug: GSK372475Drug |
Who may qualify
- Ages
- 18 years and older
- 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 and psychiatric history (including family history), full physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 45 years of age (young healthy population) and >65 years old (elderly population).
- 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
- Child-bearing potential and agrees to use of specific contraception methods. Use of oral contraception is permitted.
Key exclusion criteria (21 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular or other heart disease, glaucoma, diabetes, hepatic, neurologic (e.g. including but not limited to seizures, stroke, cerebrovascular disease or other brain conditions), or allergic disease (except for untreated, asymptomatic, seasonal allergies at time of dosing).
- Psychiatric illness currently or within the past year, or any lifetime history of bipolar disorder, major depressive disorder, anxiety disorder, schizophrenia or other psychotic disorder, or substance abuse or dependence (except past history of nicotine abuse/dependence).
- Subjects who, in the investigator's judgment, pose a suicidal or homicidal risk, or any subject with a history of suicidal or homicidal attempts or behaviour.
- 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.
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 |
|---|---|---|
| GSK3724751.5mg for 28 days | Drug | GSK372475 |
Primary outcome
Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro.
Time frame: pre-dose to 24 hours post dose
1 secondary outcome
Safety and tolerability endpoints, including adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory tests.
Time frame: from dosing to follow-up
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 Jul 2017.
- Results for study 105467 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 GSK372475 in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Germany.
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 21 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 Jul 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 Germany. 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?
Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro. (time frame: pre-dose to 24 hours post dose). 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 Jul 2017.