Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00743405
First received: August 27, 2008
Last updated: May 29, 2009
Last verified: May 2009
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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
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 May 23, 2013