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GSK372475 PK Study in Healthy Volunteers

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GSK372475
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Young, Elderly, Randomised, GSK372475

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluation including medical and psychiatric history (including family history), full physical examination, laboratory tests and cardiac monitoring.
  • Male or female between 18 and 45 years of age (young healthy population) and >65 years old (elderly population).
  • A female subject is eligible to participate if she is of:
  • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
  • Child-bearing potential and agrees to use of specific contraception methods. Use of oral contraception is permitted.
  • BMI within the range 19 - 29 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
  • Able to swallow and retain oral medication

Exclusion Criteria:

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular or other heart disease, glaucoma, diabetes, hepatic, neurologic (e.g. including but not limited to seizures, stroke, cerebrovascular disease or other brain conditions), or allergic disease (except for untreated, asymptomatic, seasonal allergies at time of dosing).
  • Psychiatric illness currently or within the past year, or any lifetime history of bipolar disorder, major depressive disorder, anxiety disorder, schizophrenia or other psychotic disorder, or substance abuse or dependence (except past history of nicotine abuse/dependence).
  • Subjects who, in the investigator's judgment, pose a suicidal or homicidal risk, or any subject with a history of suicidal or homicidal attempts or behaviour.
  • The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).
  • 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 an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 60 days i.e. 5 half-lives.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) 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 of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK 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.
  • Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  • Lactating females.
  • Administration of a monoamine oxidase inhibitor (MAOI) within 30 days prior to Study Day 1, or anticipated use within 12 weeks following the last dose of study drug.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Consumption of grapefruit juice or grapefruit or cruciferous vegetables (e.g. broccoli, Brussels sprouts, cabbage, cauliflower, chard, kale, mustard greens, rutabagas and turnips) and charbroiled foods within 7 days prior to first dose of study medication until follow-up.
  • Controlled or uncontrolled hypertension, or systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening or prior to the first dose of study medication.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GSK372475

Arm Description

Drug

Outcomes

Primary Outcome Measures

Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro.

Secondary Outcome Measures

Safety and tolerability endpoints, including adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory tests.

Full Information

First Posted
July 31, 2008
Last Updated
July 11, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00728208
Brief Title
GSK372475 PK Study in Healthy Volunteers
Official Title
A Placebo-controlled, Single-blind, Randomised, Parallel Group, 28-day Repeat Dose Study to Investigate the Tolerability, Safety and Steady State Pharmacokinetics of GSK372475 in Healthy Young and Elderly, Male and Female Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 28, 2008 (Actual)
Primary Completion Date
December 29, 2008 (Actual)
Study Completion Date
December 29, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will consist of 4 parallel cohorts of healthy volunteers (elderly male, elderly female, young male and young female). Subjects will receive either GSK372475 1.5mg or placebo for 28 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Young, Elderly, Randomised, GSK372475

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSK372475
Arm Type
Experimental
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
GSK372475
Intervention Description
1.5mg for 28 days
Primary Outcome Measure Information:
Title
Main pharmacokinetic parameters after single and repeat administration: Cmax, tmax, AUC(0-t), AUC(0-tau), Ctau and Ro.
Time Frame
pre-dose to 24 hours post dose
Secondary Outcome Measure Information:
Title
Safety and tolerability endpoints, including adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory tests.
Time Frame
from dosing to follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy as determined by a responsible physician, based on a medical evaluation including medical and psychiatric history (including family history), full physical examination, laboratory tests and cardiac monitoring. Male or female between 18 and 45 years of age (young healthy population) and >65 years old (elderly population). A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea Child-bearing potential and agrees to use of specific contraception methods. Use of oral contraception is permitted. BMI within the range 19 - 29 kg/m2 (inclusive). Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block. Able to swallow and retain oral medication Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular or other heart disease, glaucoma, diabetes, hepatic, neurologic (e.g. including but not limited to seizures, stroke, cerebrovascular disease or other brain conditions), or allergic disease (except for untreated, asymptomatic, seasonal allergies at time of dosing). Psychiatric illness currently or within the past year, or any lifetime history of bipolar disorder, major depressive disorder, anxiety disorder, schizophrenia or other psychotic disorder, or substance abuse or dependence (except past history of nicotine abuse/dependence). Subjects who, in the investigator's judgment, pose a suicidal or homicidal risk, or any subject with a history of suicidal or homicidal attempts or behaviour. The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies). 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 an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 60 days i.e. 5 half-lives. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) 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 of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK 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. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing. Lactating females. Administration of a monoamine oxidase inhibitor (MAOI) within 30 days prior to Study Day 1, or anticipated use within 12 weeks following the last dose of study drug. Unwillingness or inability to follow the procedures outlined in the protocol. History of sensitivity to heparin or heparin-induced thrombocytopenia. Consumption of grapefruit juice or grapefruit or cruciferous vegetables (e.g. broccoli, Brussels sprouts, cabbage, cauliflower, chard, kale, mustard greens, rutabagas and turnips) and charbroiled foods within 7 days prior to first dose of study medication until follow-up. Controlled or uncontrolled hypertension, or systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening or prior to the first dose of study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13251
Country
Germany

12. IPD Sharing Statement

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GSK372475 PK Study in Healthy Volunteers

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