AtherosclerosisPhase 1NCT00551317
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
A Phase 1 study testing Darapladib (SB480848) in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients Read more about this study
- Who is it for?
- Ages 20 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Darapladib (SB480848)
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2007
- 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 20 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese males, 20-64 years of age, inclusive
- Body weight >50Kg
- Body Mass Index (BMI): 18-28
- Subjects must have lived outside of Japan no more than 10 years
- Non-smoker or smokes fewer than 10 cigarettes/day
Who cannot join
- History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- History of alcohol/drug abuse or dependence within 12 months of the study
- Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
- History of cholecystectomy or biliary tract disease or history of liver disease
- Participation in a clinical study within 30 days prior to first dose
Show all 9Show fewer
- Subject has been exposed to more than 4 chemical entities within 12 months
- Positive urine drug and alcohol at screening
- Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
- Conditions
- Atherosclerosis
- Being tested
- Darapladib (SB480848)
- Keywords
- SB480848,, Japanese healthy volunteers, darapladib,
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darapladib (SB480848)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Safety/tolerability of single oral doses of darapladib
Measured: 4, 24 and 96h post-dose
- Primary Pharmacokinetic parameters of single oral doses of darapladib
Measured: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose
Secondary outcomes (1)
-Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Double blind
- Enrolment
- 18 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
- NCT00551317
- Sponsor's protocol ID
- LPL110077
- Status last verified
- Dec 2016
- First submitted
- 29 Oct 2007
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT00551317
- Acronym / sponsor ID
- LPL110077
- Conditions
- Atherosclerosis
- Keywords
- SB480848,, Japanese healthy volunteers, darapladib,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 30 Oct 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.
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese males, 20-64 years of age, inclusive
- Body weight >50Kg
- Body Mass Index (BMI): 18-28
- Subjects must have lived outside of Japan no more than 10 years
- Non-smoker or smokes fewer than 10 cigarettes/day
Key exclusion criteria (9 listed)
- History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- History of alcohol/drug abuse or dependence within 12 months of the study
- Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
- History of cholecystectomy or biliary tract disease or history of liver disease
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 |
|---|---|---|
| Darapladib (SB480848) | Drug | – |
Primary outcome
- Safety/tolerability of single oral doses of darapladib
Time frame: 4, 24 and 96h post-dose
- Primary Pharmacokinetic parameters of single oral doses of darapladib
Time frame: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose
1 secondary outcome
-Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK
Time frame: Throughout 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 5 Dec 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 Darapladib (SB480848) in people with Atherosclerosis, 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 5 inclusion and 9 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 5 Dec 2016. 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?
- Safety/tolerability of single oral doses of darapladib (time frame: 4, 24 and 96h 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 5 Dec 2016.