Safety, tolerability and pharmacokinetics of GSK1034702 in healthy subjects
Trial overview
•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.
Timeframe: 20 weeks
Assessment of the Bond-Lader Visual Analogue Scale.
Timeframe: 20 weeks
Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.
Timeframe: 20 weeks
Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.
Timeframe: 20 weeks
- 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 positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B , Hepatitis C or HIV.
- 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
•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.
- 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.
•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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.