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Healthy SubjectsPhase 1NCT00443170

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

A Phase 1 study testing omeprazole, caffeine, flurbiprofen, rosiglitazone in people with Healthy Subjects and Anaemia, run by GlaxoSmithKline at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Anaemia
What is being tested?
omeprazole, caffeine, flurbiprofen, rosiglitazone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
3 sitesAustralia
Study dates
Nov 2006to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

Australia3 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Herston, Queensland, 4006

  • GSK Investigational Site

    Randwick, Sydney, New South Wales, 2031

Other trials in Australia

About this study

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

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.

Being tested
GSK626616, placebo, midazolam, omeprazole, caffeine, flurbiprofen, rosiglitazone
Keywords
repeat dose,, GSK626616AC,, pharmacokinetic,, single dose,, cytochrome P450,, First time in human,, healthy volunteers
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK626616, placebo, midazolamDrug

  • omeprazole, caffeine, flurbiprofen, rosiglitazoneDrug

    Also called omeprazole, caffeine, flurbiprofen, rosiglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events at end of each cohort

    Measured: end of each cohort

  2. hematology/chemistry/urinalysis at end of each cohort

    Measured: end of each cohort

  3. physical examination at end of each cohort

    Measured: end of each cohort

  4. vital signs and electrocardiogram (ECG) at end of each cohort

    Measured: end of each cohort

Secondary outcomes (5)

  1. GSK626616 pharmacokinetics at end of each cohort

    Measured: end of each cohort

  2. hemoglobin at end of each cohort

    Measured: end of each cohort

  3. red blood cell measurements at end of each cohort

    Measured: end of each cohort

  4. estimates of CYP enzyme activity at end of study

    Measured: end of study

  5. mRNA levels in peripheral blood at end of study

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2007 (estimated)
  2. Study startNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00443170
Sponsor's protocol ID
YAK106752
Status last verified
Feb 2011
First submitted
1 Mar 2007
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing omeprazole, caffeine, flurbiprofen, rosiglitazone in people with Healthy Subjects and Anaemia, run by GlaxoSmithKline at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events at end of each cohort (time frame: end of each cohort). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00443170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.

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