A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects

NCT00443170 | Completed Phase 1

• 1 other identifier: YAK106752
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.

Conditions

Healthy Subjects; Anaemia

Keywords

repeat dose,; GSK626616AC,; pharmacokinetic,; single dose,; cytochrome P450,; First time in human,; healthy volunteers

Outcome Measures

Primary Outcomes (4)

• adverse events at end of each cohort

  end of each cohort

• hematology/chemistry/urinalysis at end of each cohort

  end of each cohort

• physical examination at end of each cohort

  end of each cohort

• vital signs and electrocardiogram (ECG) at end of each cohort

  end of each cohort

Secondary Outcomes (5)

• GSK626616 pharmacokinetics at end of each cohort

  end of each cohort

• hemoglobin at end of each cohort

  end of each cohort

• red blood cell measurements at end of each cohort

  end of each cohort

• estimates of CYP enzyme activity at end of study

  end of study

• mRNA levels in peripheral blood at end of study

  end of study

Interventions

GSK626616, placebo, midazolam DRUG

omeprazole, caffeine, flurbiprofen, rosiglitazone DRUG

Also known as: omeprazole, caffeine, flurbiprofen, rosiglitazone, GSK626616, placebo, midazolam

Eligibility Criteria

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

You may qualify if:

• Age 18 to 55 years healthy subjects
• Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
• Females cannot be pregnant.

You may not qualify if:

• Cannot have exposure to greater than 4 new chemical entities within 12 months.
• Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
• Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
• Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
• Cannot use be taking prescription, non-prescription or illicit drugs.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

GSK Investigational Site

Herston, Queensland, 4006, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Anemia

Interventions

Midazolam; Omeprazole; Caffeine; Flurbiprofen; Rosiglitazone

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Xanthines; Alkaloids; Purinones; Purines; Propionates; Acids, Acyclic; Carboxylic Acids; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Thiazolidinediones; Thiazoles; Azoles

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 5, 2007
• Study Start: November 1, 2006
• Last Updated: March 19, 2012

Record last verified: 2011-02

Locations

AU (3)