Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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cannot be withdrawn from oral azithromycin during study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.
