Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00743405
First received: August 27, 2008
Last updated: May 29, 2009
Last verified: May 2009
  Purpose

This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.


Condition Intervention Phase
Schizophrenia
Drug: GSK1034702
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single-Blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • •Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702. [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • Assessment of the Bond-Lader Visual Analogue Scale. [ Time Frame: 20 weeks ]
  • Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone. [ Time Frame: 20 weeks ]
  • Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters. [ Time Frame: 20 weeks ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 1 Drug: GSK1034702
Oral or liquid
Other Name: GSK1034702
Drug: Placebo
To match GSK1034702
Cohort 2 Drug: GSK1034702
Oral or liquid
Other Name: GSK1034702
Drug: Placebo
To match GSK1034702

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
  • Male or female between 18 and 55 years of age.
  • A female subject is eligible to participate if she is of non-childbearing potential
  • Body weight > 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
  • Demonstrates no evidence of mental impairment.
  • No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview

Exclusion Criteria:

  • A positive pre-study drug/alcohol screen.
  • A positive pre-study Hepatitis B , Hepatitis C or HIV.
  • History of regular alcohol consumption.
  • 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: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • 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 .
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
  • 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, females planning pregnancy or lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Subjects with a current or a history of psychiatric illness.
  • Subjects with any history of suicidal attempts or behavior.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
  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: NCT00743405

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00743405     History of Changes
Other Study ID Numbers: 110623
Study First Received: August 27, 2008
Last Updated: May 29, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
M1 receptor agonist
schizophrenia
GSK1034702
safety
pharmacokinetics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014