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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects, Anaemia

Intervention / Treatment
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* Drug: GSK626616, placebo, midazolam
* Drug: omeprazole, caffeine, flurbiprofen, rosiglitazone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK626616, placebo, midazolam|nan|
|Drug: omeprazole, caffeine, flurbiprofen, rosiglitazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repeat dose,, GSK626616AC,, pharmacokinetic,, single dose,, cytochrome P450,, First time in human,, healthy volunteers