Cystic FibrosisPhase 1NCT00605761
SD Cystic Fibrosis Study
A Phase 1 study testing SB656933 in people with Cystic Fibrosis, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability. This study will characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis. There will be two groups of subjects. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- SB656933
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have Cystic Fibrosis
- Male greater or equal to 18 years of age or female greater or equal to 16 years of age.
- Must not be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months
- Must be clinically stable with no change in symptoms or medication, no admissions to hospital, no intravenous antibiotic therapy for at least 2 weeks before study start.
- Able to perform lung function tests
- Lung test reading with FEV1 >40% predicted
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- Lung test with FEV1 has not changed by >10% over past 12 months
- Must have a normal ECG.
- Women of child bearing potential must use an effective method of contraception.
- Male subjects must agree to abstain from or use a condom during sexual intercourse or use a condom/spermicide, in addition to having their female partner use another form of contraception.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal at study start.
- Signed and dated written informed consent.
- The parent/guardian must give written informed consent for the child to participate in this investigation. Adolescents must also sign the informed consent
- The subject is able to understand and follow protocol.
Who cannot join
- Any clinically abnormality found at screening that is not part of the disease of cystic fibrosis.
- any problem with pancrease
- fatty feces
- liver problems
- sudden weight loss or poor nutritional status.
- high blood pressure
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- infected with the hepatitis B, hepatitis C, or HIV virus
- History of regular alcohol use
- a current non-smoker
- uses corticosteroids; regular use of high dose NSAIDs, within 2 months of study start.
- have had positive Burkholderia cepacia, or MRSA within the last 12 months
- on treatment for any mycobacterial infection
- cannot be withdrawn from oral azithromycin during study
- any marked bleeding haemoptysis in the last 12 months.
- has taken more than 4 new chemical entities within the last year.
- donate more than 500 mL within the last 56 day.
- taken part in a drug trial in 30 days or taken part in a trial with a new chemical within the last 2 months.
- on drugs that are CYP3A4, CYP2B6, CYP2C8 or OATP1B1 substrates with a narrow therapeutic index are excluded.
- using non-prescription drugs, including, herbal and dietary supplements (including St John's Wort) within 7 days or unless permitted by the Investigator and sponsor
- Consumption of grapefruit juice in last 7 seven day before study start.
- Pregnant or breast feeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Palo Alto, California, 94304
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Open Label Dose Ascending, Single Dose Study to Investigate the Pharmacokinetics of SB-656933 in Subjects With Cystic Fibrosis.
Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability. This study will characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis. There will be two groups of subjects. The first group of subjects will receive a single dose of 50mg SB-656933. The second group of subjects will receive a single dose of up to 300 mg SB-656933. Subjects will first be screened for eligibility related to cystic fibrosis history. Safety evaluations will be undertaken and plasma samples for pharmacokinetic analysis will be collected. Additional blood samples will be taken for the pharmacodynamic endpoints CD11b and GAFS. Subjects are not required to stay overnight after their 12 hour PK sample collection on Day 1, although they may do so if they wish. On Day 2 and 3, they will return for collection of additional safety measurements, and further plasma and blood samples will be taken for 24 and 48 h pharmacokinetics and 24h CD11b/GAFS measurements, respectively.
A follow up visit (Visit 3) will be made 4-7 days after the treatment period. Subjects will be enrolled in the study for approximately 3to 7 weeks (from screening to follow-up).
- Conditions
- Cystic Fibrosis
- Being tested
- SB656933
- Keywords
- Cystic Fibrosis, Lung function, Anti-Inflammatory
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB656933Drug
50 mg treatment
SB656933Drug
150 mg treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 50 mg treatment Receives: Drug: SB656933 |
| Cohort 2 | Experimental | 150 mg treatment Receives: Drug: SB656933 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples
Measured: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933
Secondary outcomes (2)
Safety: ECG, vital signs, clinical labs
Measured: over 48hours post SB656933 dosing in both dosing sessions
Continuous adverse event monitoring
Measured: from dosing until study conclusion and follow up, 4-7 days after the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 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
- NCT00605761
- Sponsor's protocol ID
- CF2110398
- Status last verified
- Apr 2011
- First submitted
- 18 Jan 2008
- Last updated
- 19 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Ascending, Single Dose Study to Investigate the Pharmacokinetics of SB-656933 in Subjects With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT00605761
- Acronym / sponsor ID
- CF2110398
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Lung function, Anti-Inflammatory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Jan 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.
Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability. This study will characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis. There will be two groups of subjects. The first group of subjects will receive a single dose of 50mg SB-656933. The second group of subjects will receive a single dose of up to 300 mg SB-656933. Subjects will first be screened for eligibility related to cystic fibrosis history. Safety evaluations will be undertaken and plasma samples for pharmacokinetic analysis will be collected. Additional blood samples will be taken for the pharmacodynamic endpoints CD11b and GAFS. Subjects are not required to stay overnight after their 12 hour PK sample collection on Day 1, although they may do so if they wish. On Day 2 and 3, they will return for collection of additional safety measurements, and further plasma and blood samples will be taken for 24 and 48 h pharmacokinetics and 24h CD11b/GAFS measurements, respectively.
A follow up visit (Visit 3) will be made 4-7 days after the treatment period. Subjects will be enrolled in the study for approximately 3to 7 weeks (from screening to follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SB65693350 mg treatment |
| Cohort 2 | Experimental | Drug: SB656933150 mg treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Have Cystic Fibrosis
- Male greater or equal to 18 years of age or female greater or equal to 16 years of age.
- Must not be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months
- Must be clinically stable with no change in symptoms or medication, no admissions to hospital, no intravenous antibiotic therapy for at least 2 weeks before study start.
- Able to perform lung function tests
Key exclusion criteria (21 listed)
- Any clinically abnormality found at screening that is not part of the disease of cystic fibrosis.
- any problem with pancrease
- fatty feces
- liver problems
- sudden weight loss or poor nutritional status.
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 |
|---|---|---|
| SB65693350 mg treatment | Drug | Cohort 1 |
| SB656933150 mg treatment | Drug | Cohort 2 |
Primary outcome
Blood samples
Time frame: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933
2 secondary outcomes
Safety: ECG, vital signs, clinical labs
Time frame: over 48hours post SB656933 dosing in both dosing sessions
Continuous adverse event monitoring
Time frame: from dosing until study conclusion and follow up, 4-7 days after the treatment period
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 19 Mar 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB656933 in people with Cystic Fibrosis, run by GlaxoSmithKline at 3 sites 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 14 inclusion and 21 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 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?
Blood samples (time frame: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933). 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 19 Mar 2012.