Disturbed Sleep Model Study.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: SB-649868; Drug: Placebo; Drug: Zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440323

OXS104094

Details and patient eligibility

About

Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.

Enrollment: 52 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
• Healthy as judged by responsible physician.
• No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
• The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion criteria

• A positive result for the pre-study urine drug/ alcohol breath screen.
• Abuse of alcohol.
• Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.

Trial design

52 participants in 4 patient groups

ADBC sequence

Experimental group

Description:

In ADBC sequence A is Placebo, B is SB-649868 10 milligram (mg), C is SB-649868 30 mg, and D is Zolpidem 10 mg. Subject will receive placebo tablets, then two 5 mg tablets of SB-649868, then 25 mg and 5 mg tablet of SB-649868. There will be wash-out period of 7 days.

Treatment:

Drug: Zolpidem

Drug: SB-649868

Drug: Placebo

BACD sequence

Experimental group

Description:

In BACD sequence subject will receive SB-649868 two tablets of 5 mg each (10 mg, B), Placebo tablets (A), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), and Zolpidem 10 mg (D). There will be wash-out period of 7 days.

Treatment:

Drug: Zolpidem

Drug: SB-649868

Drug: Placebo

CBDA sequence

Experimental group

Description:

In CBDA sequence subject will receive SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), SB-649868 two tablets of 5 mg each (10 mg, B), Zolpidem 10 mg (D) and Placebo tablet (A). There will be wash-out period of 7 days.

Treatment:

Drug: Zolpidem

Drug: SB-649868

Drug: Placebo

DCAB sequence

Experimental group

Description:

In DCAB sequence subject will receive Zolpidem 10 mg (D), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), Placebo tablet (A), and SB-649868 two tablets of 5 mg each (10 mg, B). There will be wash-out period of 7 days.

Treatment:

Drug: Zolpidem

Drug: SB-649868

Drug: Placebo