Last updated: 11/04/2018 05:54:15
SD Cystic Fibrosis Study
GSK study ID
CF2110398
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open label dose ascending, single dose study to investigate the pharmacokinetics of SB-656933 in subjects with cystic fibrosis.
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Non-randomized
Primary outcomes:
Blood samples
Timeframe: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933
Secondary outcomes:
Safety: ECG, vital signs, clinical labs
Timeframe: over 48hours post SB656933 dosing in both dosing sessions
Continuous adverse event monitoring
Timeframe: from dosing until study conclusion and follow up, 4-7 days after the treatment period
Interventions:
Drug: SB656933
Enrollment:
9
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cystic Fibrosis
Product
elubrixin
Collaborators
Not applicable
Study date(s)
February 2008 to December 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
16+ years
Accepts healthy volunteers
No
- Have Cystic Fibrosis
- Male greater or equal to 18 years of age or female greater or equal to 16 years of age.
- Any clinically abnormality found at screening that is not part of the disease of cystic fibrosis.
- any problem with pancrease
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
PITTSBURGH, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
MINNEAPOLIS, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
PALO ALTO, California, United States, 94304
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-31-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website