Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

NCT00743405 | Completed Phase 1

• 1 other identifier: 110623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Disorders

Keywords

schizophrenia; M1 receptor agonist; safety; pharmacokinetics; GSK1034702

Outcome Measures

Primary Outcomes (1)

• •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.

  20 weeks

Secondary Outcomes (3)

• Assessment of the Bond-Lader Visual Analogue Scale.

  20 weeks

• Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.

  20 weeks

• Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.

  20 weeks

Study Arms (2)

Cohort 1

OTHER

Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan

Drug: GSK1034702; Drug: Placebo

Cohort 2

OTHER

Subjects will be receive GSK1034702 5 mg following the dose escalation plan

Drug: GSK1034702; Drug: Placebo

Interventions

GSK1034702 DRUG

Oral or liquid

Cohort 1; Cohort 2

Placebo DRUG

To match GSK1034702

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Links

• Results for study 110623 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Cognitive Dysfunction; Schizophrenia

Interventions

GSK 1034702

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic 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: August 27, 2008
• First Posted: August 28, 2008
• Study Start: May 2, 2008
• Primary Completion: December 15, 2008
• Study Completion: December 15, 2008
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

GB (1)