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WithdrawnNCT00534872Updated Apr 17, 2015

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

A Phase 1 interventional study of SB-649868 in Insomnia, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Why this study was withdrawn
The study was stoppend before recruitment start for preclinical safety finding in rats.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Insomnia

Keywords

  • 4 Parallel cohorts
  • Healthy Female
  • Healthy Elderly
  • Pharmacokinetic
  • Safety and Tolerability
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult and elderly female and male
  • Female must be of non-childbearing potential
  • Body weight =50 kg

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    SB649868

    10 mg

    Drug: SB-649868

Interventions

  • DrugSB-649868

    10 mg

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

Secondary outcomes

  1. Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868

    Time frame: within 7-14 days from a single dose of SB-649868

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00534872
Lead sponsor
GlaxoSmithKline
First posted
Sep 26, 2007
Start date
Oct 2007
Primary completion
Oct 2007 (estimated)
Completion
Oct 2007 (estimated)
Last update
Apr 17, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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