Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

Cognitive Disorders Clinical Trial

Official title:

Single-blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743405
• Other study ID #: 110623
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2008
• Last updated: July 18, 2017
• Start date: May 2, 2008
• Est. completion date: December 15, 2008

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 15, 2008
• Est. primary completion date: December 15, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders

Intervention

Drug:
• GSK1034702
Oral or liquid
• Placebo
To match GSK1034702

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•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	Assessment of the Bond-Lader Visual Analogue Scale.		20 weeks
Secondary	Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.		20 weeks
Secondary	Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.		20 weeks

External Links

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