Depressive Disorder and Anxiety DisordersPhase 1FTIMNCT01031186
First Time in Human Study
A Phase 1 study testing GSK356278 in people with Depressive Disorder and Anxiety Disorders, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder and Anxiety Disorders
- What is being tested?
- GSK356278
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Nov 2009to 7 Apr 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AST, ALT, alkaline phosphate and bilirubin less than or equal to 1.5 times upper limit of normal.
- Healthy as determined by a responsible and experienced physician based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Males aged between 18 and 65 years inclusive at the time of signing the informed consent.
- Males must agree to appropriate forms of contraception from administration of first dose through to 3 months after taking the final dose.
- Body weight greater than or equal to 50 kg and BMI within the range of 18-29.9 m2 (inclusive)
- Capable of giving written informed consent.
- QTcB or QTcF less than 450 msec
Who cannot join
- A positive pre-study Hep B or positive Hep C result within 3 months of screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities
- A positive pre-study alcohol and drug screen
- 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 average daily intake of greater than 3 units
- The subject has participated in a clinical trial and has received investigational product within the time period of 30 days prior to first dosing day (or 5 half-lives or twice the duration of the biological effect of the drug, whichever is longer)
Show all 18Show fewer
- Exposure to more than 4 new chemical entities in the last 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements 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 unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medication or history of drug or other allergy that in the opinion of the investigator or 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.
- Unwillingness or inability to follow the procedures in the protocol.
- Subject is mentally or legally incapacitated.
- Subjects who have asthma or a history of asthma.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco or nicotine containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose.
- History of any significant psychiatric illness.
- Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale in the last 6 months.
- History of presence of clinically significant cardiac arrhythmias or other clinically significant cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK356278 (PDE4 Inhibitor) in Healthy Volunteers
This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male volunteers
Read the detailed description
To evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK356278 and may assess the effect of food on GSK356278 pharmacokinetics. They study will assess the compound's effect on nausea, emesis and alertness. Close monitoring of cardiovascular parameters will be included.
- Being tested
- GSK356278, PLACEBO
- Keywords
- healthy male volunteers, GSK356278, first time in man, major depressive disorder
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK356278Drug
GSK356278
PLACEBODrug
PLACEBO
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Session 1 | Experimental | In Dosing Session 1, the subjects will be administered 0.5 mg GSK356278 and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 1, Session 2 | Experimental | In Dosing Session 2, the subjects will be administered GSK356278 (0.5 mg and 1.5 mg) and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 1, Session 3 | Experimental | In Dosing Session 3, the subjects will be administered GSK356278 (1.5 mg and 4 mg) and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 1, Session 4 | Experimental | In Dosing Session 4, the subjects will be administered GSK356278 (4 mg and 8 mg) and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 1, Session 5 | Experimental | In Dosing Session 5, the subjects will be administered GSK356278 8 mg and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 2, Session 1 | Experimental | In Dosing Session 1, the subjects will be administered 8 mg GSK356278 and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 2, Session 2 | Experimental | In Dosing Session 2, the subjects will be administered GSK356278 (8 mg and 16 mg) and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 2, Session 3 | Experimental | In Dosing Session 3, the subjects will be administered GSK356278 (16 mg and 30 mg) and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 2, Session 4 | Experimental | In Dosing Session 4, the subjects will be administered GSK356278 (30 mg and 50 mg) and placebo in a fasted state. Receives: Drug: GSK356278; Drug: PLACEBO |
| Cohort 2, Session 5 | Experimental | In Dosing Session 5, the subjects will be administered GSK356278 50 mg and placebo in a fasted state. The subjects will undergo food assessment session in Session 5 incase they experience nausea. In food assessment session, the subjects will receive a dose of GSK356278 after a standard breakfast. Receives: Drug: GSK356278; Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers
Measured: 72 hours
Secondary outcomes (1)
To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start23 Nov 2009
- Primary completion7 Apr 2010
- Study completion7 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder and Anxiety DisordersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT01031186
- Sponsor's protocol ID
- 113324
- Acronym
- FTIM
- Status last verified
- Jul 2017
- First submitted
- 5 Nov 2009
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK356278 (PDE4 Inhibitor) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01031186
- Acronym / sponsor ID
- FTIM / 113324
- Keywords
- healthy male volunteers, GSK356278, first time in man, major depressive disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2009 (actual)
- Primary completion
- 7 Apr 2010 (actual)
- Study completion
- 7 Apr 2010 (actual)
- First posted
- 14 Dec 2009 (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 evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male volunteers
Detailed description
To evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK356278 and may assess the effect of food on GSK356278 pharmacokinetics. They study will assess the compound's effect on nausea, emesis and alertness. Close monitoring of cardiovascular parameters will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Session 1 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 1, the subjects will be administered 0.5 mg GSK356278 and placebo in a fasted state. |
| Cohort 1, Session 2 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 2, the subjects will be administered GSK356278 (0.5 mg and 1.5 mg) and placebo in a fasted state. |
| Cohort 1, Session 3 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 3, the subjects will be administered GSK356278 (1.5 mg and 4 mg) and placebo in a fasted state. |
| Cohort 1, Session 4 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 4, the subjects will be administered GSK356278 (4 mg and 8 mg) and placebo in a fasted state. |
| Cohort 1, Session 5 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 5, the subjects will be administered GSK356278 8 mg and placebo in a fasted state. |
| Cohort 2, Session 1 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 1, the subjects will be administered 8 mg GSK356278 and placebo in a fasted state. |
| Cohort 2, Session 2 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 2, the subjects will be administered GSK356278 (8 mg and 16 mg) and placebo in a fasted state. |
| Cohort 2, Session 3 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 3, the subjects will be administered GSK356278 (16 mg and 30 mg) and placebo in a fasted state. |
| Cohort 2, Session 4 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 4, the subjects will be administered GSK356278 (30 mg and 50 mg) and placebo in a fasted state. |
| Cohort 2, Session 5 | Experimental | Drug: GSK356278, Drug: PLACEBOIn Dosing Session 5, the subjects will be administered GSK356278 50 mg and placebo in a fasted state. The subjects will undergo food assessment session in Session 5 incase they experience nausea. In food assessment session, the subjects will receive a dose of GSK356278 after a standard breakfast. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- AST, ALT, alkaline phosphate and bilirubin less than or equal to 1.5 times upper limit of normal.
- Healthy as determined by a responsible and experienced physician based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Males aged between 18 and 65 years inclusive at the time of signing the informed consent.
- Males must agree to appropriate forms of contraception from administration of first dose through to 3 months after taking the final dose.
- Body weight greater than or equal to 50 kg and BMI within the range of 18-29.9 m2 (inclusive)
Key exclusion criteria (18 listed)
- A positive pre-study Hep B or positive Hep C result within 3 months of screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities
- A positive pre-study alcohol and drug screen
- 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 average daily intake of greater than 3 units
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 |
|---|---|---|
| GSK356278GSK356278 | Drug | Cohort 1, Session 1, Cohort 1, Session 2, Cohort 1, Session 3, Cohort 1, Session 4, Cohort 1, Session 5, Cohort 2, Session 1, Cohort 2, Session 2, Cohort 2, Session 3, Cohort 2, Session 4, Cohort 2, Session 5 |
| PLACEBOPLACEBO | Drug | Cohort 1, Session 1, Cohort 1, Session 2, Cohort 1, Session 3, Cohort 1, Session 4, Cohort 1, Session 5, Cohort 2, Session 1, Cohort 2, Session 2, Cohort 2, Session 3, Cohort 2, Session 4, Cohort 2, Session 5 |
Primary outcome
To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers
Time frame: 72 hours
1 secondary outcome
To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers
Time frame: 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 Jul 2017.
- Results for study 113324 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GSK356278 in people with Depressive Disorder and Anxiety Disorders, 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 7 inclusion and 18 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 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 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?
To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers (time frame: 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 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.