An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.

NCT00423761 | Completed Phase 1

• 1 other identifier: CRH103152
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.

Conditions

Healthy Subjects

Keywords

Pharmacokinetics,; tolerability,; healthy,; subjects

Outcome Measures

Primary Outcomes (1)

• Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.

  on Day 1 of Session 1 and on Days 1 and 14 of Session 2.

Secondary Outcomes (2)

• 12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2

  day 1 session 1; days 1 & 14 session 2

• vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2

  day 1 session 1; days 1, 7 & 14 session 2

Interventions

midazolam DRUG

GW876008 DRUG

Also known as: midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females.
• Normal ECG.
• Agree to remain in the clinic for the time defined in the protocol.
• Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

You may not qualify if:

• Any serious medical disorder or condition.
• Any history of an endocrine disorder.
• Any clinically significant laboratory abnormality.
• History of psychiatric illness.
• Any history of suicidal attempts or behavior.
• Active peptic ulcer disease.
• Positive faecal occult blood.
• The subject smokes or has smoked or has used any nicotine-containing products in the last six months.
• Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Midazolam; GW 876008

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials, MBChB, MFPM

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: December 1, 2006
• Last Updated: May 18, 2009

Record last verified: 2009-05

Locations

US (1)