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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00443170

Enrollment

Registered

2007-03-05

Start date

2006-11-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia, Healthy Subjects

Keywords

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

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.

Interventions

DRUGGSK626616, placebo, midazolam

DRUGomeprazole, caffeine, flurbiprofen, rosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
GSK626616 pharmacokinetics at end of each cohort	end of each cohort
mRNA levels in peripheral blood at end of study	end of study
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026