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Completed

NCT Number: NCT00443170

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

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.

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Key information

Conditions

Healthy Subjects Anaemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Randwick, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

GSK626616, placebo, midazolam

Drug

omeprazole, caffeine, flurbiprofen, rosiglitazone

Drug

Other names: omeprazole, caffeine, flurbiprofen, rosiglitazone, GSK626616, placebo, midazolam

Primary outcomes

  1. adverse events at end of each cohort

    Time frame: end of each cohort

  2. hematology/chemistry/urinalysis at end of each cohort

    Time frame: end of each cohort

  3. physical examination at end of each cohort

    Time frame: end of each cohort

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

    Time frame: end of each cohort

Secondary outcomes

  1. GSK626616 pharmacokinetics at end of each cohort

    Time frame: end of each cohort

  2. hemoglobin at end of each cohort

    Time frame: end of each cohort

  3. red blood cell measurements at end of each cohort

    Time frame: end of each cohort

  4. estimates of CYP enzyme activity at end of study

    Time frame: end of study

  5. mRNA levels in peripheral blood at end of study

    Time frame: end of study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Blinded, Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Single and Repeat Dose Escalation of the Oral YAK3/DYRK3 Inhibitor GSK626616AC in Healthy Subjects

Important dates

Study start
2006
First posted
Mar 5, 2007
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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