Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00443170




Registration number
NCT00443170
Ethics application status
Date submitted
1/03/2007
Date registered
5/03/2007
Date last updated
19/03/2012

Titles & IDs
Public title
A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
YAK106752
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Anaemia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK626616, placebo, midazolam
Treatment: Drugs - omeprazole, caffeine, flurbiprofen, rosiglitazone

Treatment: Drugs: GSK626616, placebo, midazolam


Treatment: Drugs: omeprazole, caffeine, flurbiprofen, rosiglitazone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
adverse events at end of each cohort
Timepoint [1] 0 0
end of each cohort
Primary outcome [2] 0 0
hematology/chemistry/urinalysis at end of each cohort
Timepoint [2] 0 0
end of each cohort
Primary outcome [3] 0 0
physical examination at end of each cohort
Timepoint [3] 0 0
end of each cohort
Primary outcome [4] 0 0
vital signs and electrocardiogram (ECG) at end of each cohort
Timepoint [4] 0 0
end of each cohort
Secondary outcome [1] 0 0
GSK626616 pharmacokinetics at end of each cohort
Timepoint [1] 0 0
end of each cohort
Secondary outcome [2] 0 0
hemoglobin at end of each cohort
Timepoint [2] 0 0
end of each cohort
Secondary outcome [3] 0 0
red blood cell measurements at end of each cohort
Timepoint [3] 0 0
end of each cohort
Secondary outcome [4] 0 0
estimates of CYP enzyme activity at end of study
Timepoint [4] 0 0
end of study
Secondary outcome [5] 0 0
mRNA levels in peripheral blood at end of study
Timepoint [5] 0 0
end of study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Herston
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00443170
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00443170