First Time in Human Study (FTIM)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01031186
First received: November 5, 2009
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

This study will evaluate the safety, tolerability, and pharmacokinetics of GSK356278 in male volunteers


Condition Intervention Phase
Depressive Disorder and Anxiety Disorders
Depressive Disorder
Anxiety Disorders
Depressive Disorder, Major
Drug: GSK356278
Drug: PLACEBO
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK356278 (PDE4 Inhibitor) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1, Session 1 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 1, Session 2 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 1, Session 3 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 1, Session 4 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 1, Session 5 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 2, Session 1 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 2, Session 2 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 2, Session 3 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 2, Session 4 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO
Experimental: Cohort 2, Session 5 Drug: GSK356278
GSK356278
Drug: PLACEBO
PLACEBO

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031186

Locations
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01031186     History of Changes
Other Study ID Numbers: 113324
Study First Received: November 5, 2009
Last Updated: October 1, 2010
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
healthy male volunteers
GSK356278
first time in man
major depressive disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Anxiety Disorders
Disease
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014