A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects; Anaemia
Intervention: GSK626616, placebo, midazolam (Drug); omeprazole, caffeine, flurbiprofen, rosiglitazone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: adverse events at end of each cohorthematology/chemistry/urinalysis at end of each cohort physical examination at end of each cohort vital signs and electrocardiogram (ECG) at end of each cohort
Secondary outcome: GSK626616 pharmacokinetics at end of each cohorthemoglobin at end of each cohort red blood cell measurements at end of each cohort estimates of CYP enzyme activity at end of study mRNA levels in peripheral blood at end of study
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Investigational Site, Randwick, Sydney, New South Wales 2031, Australia
GSK Investigational Site, Herston, Queensland 4006, Australia
GSK Investigational Site, Adelaide, South Australia 5000, Australia
Additional Information
Starting date: November 2006
Last updated: March 15, 2012
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