A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population

Insomnia Clinical Trial

Official title:

A Single-centre, Open Label, Single-dose, Four Parallel Cohorts Study to Investigate the Pharmacokinetics, Safety and Tolerability of SB-649868 10mg in Healthy Female "Non-childbearing Potential", Healthy Male and in Healthy Elderly Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00534872
• Other study ID #: OXS109143
• Status: Withdrawn
• Phase: Phase 1
• First received: September 24, 2007
• Last updated: April 15, 2015
• Start date: October 2007
• Est. completion date: October 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• Healthy adult and elderly female and male

• Female must be of non-childbearing potential

• Body weight =50 kg

EXCLUSION CRITERIA:

• Abuse of alcohol or drugs

• Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV

• Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication

• Smoking history of = 10 cigarettes a day in the last three months

• History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases

• Participation in clinical trial during the previous 6 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• SB-649868
10 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours		single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours	No
Secondary	Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868		within 7-14 days from a single dose of SB-649868