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Trial details imported from ClinicalTrials.gov
Ethics application status
First Time in Human Study
A First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK356278 (PDE4 Inhibitor) in Healthy Volunteers
Universal Trial Number (UTN)
Depressive Disorder and Anxiety Disorders
Description of intervention(s) / exposure
Treatment: Drugs - GSK356278
Treatment: Drugs - PLACEBO
Experimental: Cohort 1, Session 1 - In Dosing Session 1, the subjects will be administered 0.5 mg GSK356278 and placebo in a fasted state.
Experimental: Cohort 1, Session 2 - In Dosing Session 2, the subjects will be administered GSK356278 (0.5 mg and 1.5 mg) and placebo in a fasted state.
Experimental: Cohort 1, Session 3 - In Dosing Session 3, the subjects will be administered GSK356278 (1.5 mg and 4 mg) and placebo in a fasted state.
Experimental: Cohort 1, Session 4 - In Dosing Session 4, the subjects will be administered GSK356278 (4 mg and 8 mg) and placebo in a fasted state.
Experimental: Cohort 1, Session 5 - In Dosing Session 5, the subjects will be administered GSK356278 8 mg and placebo in a fasted state.
Experimental: Cohort 2, Session 1 - In Dosing Session 1, the subjects will be administered 8 mg GSK356278 and placebo in a fasted state.
Experimental: Cohort 2, Session 2 - In Dosing Session 2, the subjects will be administered GSK356278 (8 mg and 16 mg) and placebo in a fasted state.
Experimental: Cohort 2, Session 3 - In Dosing Session 3, the subjects will be administered GSK356278 (16 mg and 30 mg) and placebo in a fasted state.
Experimental: Cohort 2, Session 4 - In Dosing Session 4, the subjects will be administered GSK356278 (30 mg and 50 mg) and placebo in a fasted state.
Experimental: Cohort 2, Session 5 - 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.
Treatment: Drugs: GSK356278
Treatment: Drugs: PLACEBO
Intervention code 
Comparator / control treatment
Primary outcome 
To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers
Secondary outcome 
To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers
Key inclusion criteria
- AST, ALT, alkaline phosphate and bilirubin less than or equal to 1.5 times upper limit
- Healthy as determined by a responsible and experienced physician based on a medical
evaluation including medical history, physical examination, laboratory tests and
- Males aged between 18 and 65 years inclusive at the time of signing the informed
- 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
- Capable of giving written informed consent.
- QTcB or QTcF less than 450 msec
Can healthy volunteers participate?
Key exclusion criteria
- 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
- 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)
- Exposure to more than 4 new chemical entities in the last 12 months prior to the first
- 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
- 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.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
GSK Investigational Site - Randwick
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male
Trial related presentations / publications
GSK Clinical Trials