Primary insomnia MedDRA version: 9.1 Level: LLT Classification code 10036701 Term: Primary insomnia
Conditions
Interventions
Product Name: GW597599
Pharmaceutical Form: Capsule, hard
Current Sponsor code: GW597599
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of
Sponsors
GlaxoSmithKline Research & Devleopment Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subjects understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleep-laboratory restrictions and procedures. 2. Subject is a male or female outpatient, at least 18 years of age and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Any clinically significant psychiatric disorder other than primary insomnia as defined by DSM-IV-TR. • Subject must not have a Beck Depression Inventory total score of 29 or greater at the Screening Visit, view protocol. 2. Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, view protocol. 3. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the past 12 months as defined by DSM-IV-TR (view protocol). 4. Positive urine drug screen or alcohol breath test at screening. No repeat test allowed, (view protocol). 5. Any clinically significant unstable medical or surgical condition (treated or untreated). 6. Any history of a clinically significant abnormality of the neurological system or any history of seizure (view protocol). 7. Subject has an unstable medical disorder; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GW597599 or GR205171; or interfere with the accurate assessment of safety or efficacy. 8. Subjects having clinically significant abnormalities in haematology, blood chemistry, ECG, urinalysis, physical exam, vital signs, or other protocol-specified screening test which are not resolved by the baseline visit. 9. Subjects with a history of clinically significant hepatic, cardiac, renal, neurologic cerebrovascular, metabolic or pulmonary disease, view protocol. 10. Any serious medical disorder or condition that would in the Investigator's opinion, preclude the administration of study medication. 11. Subjects who have any laboratory value outside the sponsor-specified ranges at the Screening Visit, view protocol. 12. Subjects who are not euthyroid as evidenced by normal TSH, view protocol. 13. Known seropositivity for human immunodeficiency virus (HIV). 14. Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody. 15. Subjects who have any electrocardiogram (ECG) parameter outside of the Sponsor-specified range. The ECG maybe repeated once to see if the parameter returns to within range, but any such abnormality must be resolved by the screening PSG session (Visits 2/3, view protocol). 16. Apnea-hypopnea index of 10 or more/hour of sleep on screening PSG Night 1. Subjects failing this criterion on Night 1 Screening PSG should not be screened on Night 2. 17. Movement arousal index of 10 or more/hour of sleep on screening PSG Night 1. Subjects failing this criterion on Night 1 Screening PSG should not be screened on Night 2. 18. Body mass index of 34 or more at Screening Visit. 19. Nightshift or rotating-shift work within the last 2 work weeks or during the study period. 20. Planned travel across more than 2 time zones during the study or in the 2 weeks prior to screening. 21. Consumption of 300 mg or more per day on average of xanthine-containing beverages over the preceding 1 month [view protocol]. 22. Smoking more than 1 pack of cigarettes per day (20 cigarettes) on average over the preceding 1 month, or inability to stop smoking during the study. 23. Typical consumption of more than 7 (women) or 14 (men) alcoholic units in any week, or more than 2 (women) or 3 (men) alcoholic units in any single day, over the preceding 1 month [view protocol]. 24. Regular intentional napping, i.e., more than 2 naps per week 25. Use of any psych
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the acute effects of GW597599 15 mg on sleep in adults with Primary Insomnia as determined objectively by polysomnography (PSG). • To evaluate the acute effects of GR205171 10 mg on sleep in adults with Primary Insomnia as determined objectively by PSG. ;Primary end point(s): • Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from PSG recording.;Secondary Objective: • To investigate the effects of GW597599 and GR205171 on subjective sleep parameters and sleep quality using the self reported Post-Sleep Questionnaire. • To evaluate the difference between GW597599 and GR205171 in the acute effects on sleep in adults with Primary Insomnia as determined objectively by PSG. • To investigate the effects of GW597599 and GR205171 on daytime cognitive functioning on the morning following dosing, including tests of alertness, memory, attention and fine motor control. • To investigate the safety and the pharmacokinetic (PK) profile of GW597599 and GR205171 in subjects with primary insomnia after 2 consecutive days of oral administration. • To investigate the relationship between plasma concentrations of GW597599 and GR205171 and sleep or cognitive parameters, and to develop a PK/PD model. | — |
Countries
Germany
Outcome results
None listed