Respiratory Tract InfectionPhase 1NCT00427141
A Three-Part Study Of GSK580416 In Healthy Subjects
A Phase 1 study testing GSK580416 in people with Respiratory Tract Infection and Infections, Bacterial, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infection, Infections, Bacterial
- What is being tested?
- GSK580416
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 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
- Healthy as determined by a physician
- Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
- Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)
Who cannot join
- Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
- Male and female subjects not willing to follow study specified contraceptive methods
- Subjects taking any recreational drugs
- Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
- Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
- Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
Show all 10Show fewer
- Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
- Use of St. John's Wort within 28 days before the first dose of study drug
- Subjects not willing to follow study specified life style restrictions
- Blood donation in excess of 500 mL within a 56 days period
Trial locations and contacts
1 site in 1 country.
Australia1 site
GSK Investigational Site
Randwick, Sydney, New South Wales, 2031
About this study
Official title: A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects
Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.
- Conditions
- Respiratory Tract Infection, Infections, Bacterial
- Being tested
- GSK580416
- Keywords
- tolerability,, pharmacokinetics,, first time in human,, food effect, safety,
- Medical subject headings
- Respiratory Tract Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK580416Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.
Measured: during the study
Secondary outcomes (1)
Blood samples to determine drug levels in the body will be collected during the study.
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 48 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
- NCT00427141
- Sponsor's protocol ID
- OPS106400
- Status last verified
- Feb 2011
- First submitted
- 24 Jan 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00427141
- Acronym / sponsor ID
- OPS106400
- Conditions
- Respiratory Tract Infection, Infections, Bacterial
- Keywords
- tolerability,, pharmacokinetics,, first time in human,, food effect, safety,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 26 Jan 2007 (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.
Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy as determined by a physician
- Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
- Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)
Key exclusion criteria (10 listed)
- Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
- Male and female subjects not willing to follow study specified contraceptive methods
- Subjects taking any recreational drugs
- Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
- Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
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 |
|---|---|---|
| GSK580416 | Drug | – |
Primary outcome
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.
Time frame: during the study
1 secondary outcome
Blood samples to determine drug levels in the body will be collected during the study.
Time frame: during the study
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 4 Jun 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 GSK580416 in people with Respiratory Tract Infection and Infections, Bacterial, run by GlaxoSmithKline at 1 site 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 10 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 4 Jun 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 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?
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study. (time frame: during the study). 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 4 Jun 2012.