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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00605761 |
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Date of registration:
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18/01/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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SD Cystic Fibrosis Study
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Scientific title:
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An Open Label Dose Ascending, Single Dose Study to Investigate the Pharmacokinetics of SB-656933 in Subjects With Cystic Fibrosis. |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00605761 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: SB656933
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Primary Outcome(s)
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Blood samples
[Time Frame: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933]
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Secondary Outcome(s)
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Continuous adverse event monitoring
[Time Frame: from dosing until study conclusion and follow up, 4-7 days after the treatment period]
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Safety: ECG, vital signs, clinical labs
[Time Frame: over 48hours post SB656933 dosing in both dosing sessions]
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Secondary ID(s)
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CF2110398
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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