NCT00495729

Brief Summary

Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2007

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

June 29, 2007

Last Update Submit

August 5, 2017

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

SB-649868,SimvastatinRepeated dose,

Outcome Measures

Primary Outcomes (3)

  • -AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)

    after the SD and 14 days RD period (15 days)

  • - SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)

    on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)

  • - Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15

    on days -10,1,4,7 and 15

Secondary Outcomes (1)

  • Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.

    on days -7, 7 and 14.

Study Arms (3)

Cohort 1

EXPERIMENTAL

Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin.

Drug: SB-649868Drug: PlaceboDrug: Simvastatin

Cohort 2

EXPERIMENTAL

Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin.

Drug: SB-649868Drug: PlaceboDrug: Simvastatin

Cohort 3

EXPERIMENTAL

Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin.

Drug: SB-649868Drug: PlaceboDrug: Simvastatin

Interventions

SB-649868DRUG

Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.

Cohort 1Cohort 2Cohort 3
PlaceboDRUG

Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.

Cohort 1Cohort 2Cohort 3
SimvastatinDRUG

Subjects will receive Simvastatin 10 mg tablets orally.

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult male subjects aged between 18 and 65 years of age inclusive.
  • 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. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
  • Subjects will have blood pressure measurements within the normal range for healthy volunteers.

You may not qualify if:

  • The subject has a positive pre-study urine drug/ alcohol urine screen.
  • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
  • Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
  • Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Berlin, 14050, Germany

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamideSimvastatin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 3, 2007

Study Start

April 18, 2007

Primary Completion

August 4, 2007

Study Completion

August 4, 2007

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

DE(1)