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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01031186




Registration number
NCT01031186
Ethics application status
Date submitted
5/11/2009
Date registered
14/12/2009
Date last updated
27/07/2017

Titles & IDs
Public title
First Time in Human Study
Scientific title
A First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK356278 (PDE4 Inhibitor) in Healthy Volunteers
Secondary ID [1] 0 0
113324
Universal Trial Number (UTN)
Trial acronym
FTIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder and Anxiety Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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
GSK356278

Treatment: Drugs: PLACEBO
PLACEBO
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers
Timepoint [1] 0 0
72 hours
Secondary outcome [1] 0 0
To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers
Timepoint [1] 0 0
72 hours

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
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
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)

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/04/2010
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male
volunteers
Trial website
https://clinicaltrials.gov/ct2/show/NCT01031186
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01031186