Healthy Subjects
Conditions
Keywords
safety,, healthy volunteers,, GW823296,, pharmacokinetics
Brief summary
This is a study to evaluate the safety, tolerability and pharmacokinetics of GW823296 following 28 days, once-daily repeat oral doses.
Interventions
DRUGGW823296
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as determined by a Physician Responsible, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring. A subject with a clinical abnormality or laboratory variables outside the reference range for the population being studied, with the exception of liver transaminases, troponin I and TSH, may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. Please note that subjects should have liver transaminases, troponin I and TSH values within the range specified in the
Exclusion criteria
below. * Male or female between 18 and 65 years of age inclusive. * A female subject is eligible to participate if she is of: * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and confirmed by screening follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml or \<140 pmol/L.. Females on hormone replacement therapy (HRT) must discontinue HRT and their post-menopausal status confirmed as per above tests prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they are not allowed to use HRT during the study. * Child-bearing potential and agrees to use one of the contraception methods as per protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 7 days after the last dose of study medication. * Male subjects must agree to use one of the contraception methods as per protocol. This criterion must be followed from the time of the first dose of study medication until at least 7 days post last dose. * No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview (M.I.N.I) scale. * Normal neurological examination performed by the study neurologist * A 12-lead ECG at screening showing no abnormalities that in the opinion of the Principal Investigator will compromise safety in this study. * Body weight \>/ 50 kg and BMI within the range 19.0 - 29.9 kg/m2 (inclusive). * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * The subject must be able to read, comprehend and record information. * A signed and dated written informed consent is obtained from the subject * The subject is available to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events, Concomitant Medication, | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination, Neurological Examination, Eye Examination, 12-lead ECG, Vital Signs, Laboratory Parameters, Pharmacokinetic Parameters | — |
Countries
Australia
Outcome results
None listed