Healthy SubjectsPhase 1NCT00608699
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
A Phase 1 study testing GSK256073A tablets + IR niacin tablets in people with Healthy Subjects and Dyslipidaemias, run by GlaxoSmithKline at 1 site in United States.
Trial summary
To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Dyslipidaemias
- What is being tested?
- GSK256073A tablets + IR niacin tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Apr 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males between 18 and 55 years of age, inclusive.
- Healthy subjects
- Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
- Subjects with QTc < 450 msec at screening
Who cannot join
- History of significant cardiac arrhythmias
- Active peptic ulcer disease (PUD) and/or history of PUD
- History of gout and/or hyperuricemia
- History of Gilbert's syndrome
- History of recurrent indigestion, stomach upset or diarrhea
- History of other than rare (once yearly or less) flushing
- Recurrent skin rash or psoriasis
- History of kidney stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.
- Conditions
- Healthy Subjects, Dyslipidaemias
- Being tested
- GSK256073A tablets + IR niacin tablets
- Keywords
- Flushing, GSK256073A,, Dose Escalation,, Immediate Release Niacin,
- Medical subject headings
- Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK256073A tablets + IR niacin tabletsDrug
single dosing for 4 to 5 sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
Measured: up to 8 hours post dose
Safety and tolerability of GSK256073A and immediate release niacin
Measured: up to 36 hours post dose
Secondary outcomes (3)
Standard and Secondary pharmacokinetic endpoints of interest
Measured: up to 36 hours post dose
Pharmacodynamic response
Measured: up to 36 hours post dose
Pharmacodynamic response
Measured: up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608699
- Sponsor's protocol ID
- HMA111316
- Status last verified
- Apr 2012
- First submitted
- 23 Jan 2008
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00608699
- Acronym / sponsor ID
- HMA111316
- Conditions
- Healthy Subjects, Dyslipidaemias
- Keywords
- Flushing, GSK256073A,, Dose Escalation,, Immediate Release Niacin,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult males between 18 and 55 years of age, inclusive.
- Healthy subjects
- Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
- Subjects with QTc < 450 msec at screening
Key exclusion criteria (8 listed)
- History of significant cardiac arrhythmias
- Active peptic ulcer disease (PUD) and/or history of PUD
- History of gout and/or hyperuricemia
- History of Gilbert's syndrome
- History of recurrent indigestion, stomach upset or diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK256073A tablets + IR niacin tabletssingle dosing for 4 to 5 sessions | Drug | – |
Primary outcome
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
Time frame: up to 8 hours post dose
Safety and tolerability of GSK256073A and immediate release niacin
Time frame: up to 36 hours post dose
3 secondary outcomes
Standard and Secondary pharmacokinetic endpoints of interest
Time frame: up to 36 hours post dose
Pharmacodynamic response
Time frame: up to 36 hours post dose
Pharmacodynamic response
Time frame: up to 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK256073A tablets + IR niacin tablets in people with Healthy Subjects and Dyslipidaemias, run by GlaxoSmithKline at 1 site in United States.
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 4 inclusion and 8 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing (time frame: up to 8 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2012.