Last updated: 11/04/2018 13:49:02
A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
GSK study ID
YAK106752
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
adverse events at end of each cohort
Timeframe: end of each cohort
hematology/chemistry/urinalysis at end of each cohort
Timeframe: end of each cohort
physical examination at end of each cohort
Timeframe: end of each cohort
vital signs and electrocardiogram (ECG) at end of each cohort
Timeframe: end of each cohort
Secondary outcomes:
GSK626616 pharmacokinetics at end of each cohort
Timeframe: end of each cohort
hemoglobin at end of each cohort
Timeframe: end of each cohort
red blood cell measurements at end of each cohort
Timeframe: end of each cohort
estimates of CYP enzyme activity at end of study
Timeframe: end of study
mRNA levels in peripheral blood at end of study
Timeframe: end of study
Interventions:
Drug: GSK626616, placebo, midazolam
Drug: omeprazole, caffeine, flurbiprofen, rosiglitazone
Enrollment:
90
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Anaemia
Product
GSK626616
Collaborators
Not applicable
Study date(s)
November 2006 to August 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
RANDWICK, SYDNEY, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
ADELAIDE, South Australia, Australia, 5000
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-06-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website