First Time in Human Study

NCT01031186 | Completed Phase 1

• 1 other identifier: 113324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

healthy male volunteers; GSK356278; first time in man; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• To assess safety and tolerability of single escalating oral doses of GSK356278 in healthy male volunteers

  72 hours

Secondary Outcomes (1)

• To investigate the pharmacokinetics of single escalating doses of GSK356278 in healthy male volunteers

  72 hours

Study Arms (10)

Cohort 1, Session 1

EXPERIMENTAL

In Dosing Session 1, the subjects will be administered 0.5 mg GSK356278 and placebo in a fasted state.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: GSK356278; Drug: PLACEBO

Interventions

GSK356278 DRUG

GSK356278

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

PLACEBO DRUG

PLACEBO

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Links

• Results for study 113324 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major

Interventions

5-(5-((2,4-dimethylthiazol-5-yl)methyl)-1,3,4-oxadiazol-2-yl)-1-ethyl-N-(tetrahydro-2H-pyran-4-yl)-1H-pyrazolo(3,4-b)pyridin-4-amine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: December 14, 2009
• Study Start: November 23, 2009
• Primary Completion: April 7, 2010
• Study Completion: April 7, 2010
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)