SD Cystic Fibrosis Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00605761

Purpose

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).

Condition	Intervention	Phase
Cystic Fibrosis	Drug: SB656933	Phase I

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: SB 656933

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open Label Dose Ascending, Single Dose Study to Investigate the Pharmacokinetics of SB-656933 in Subjects With Cystic Fibrosis.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Blood samples [ Time Frame: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	16
Study Start Date:	February 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605761

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

United States, California
GSK Investigational Site	Completed
Palo Alto, California, United States, 94304
United States, Minnesota
GSK Investigational Site	Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
GSK Investigational Site	Recruiting
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CF2110398
Study First Received:	January 18, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00605761
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Cystic Fibrosis
Lung function
Anti-Inflammatory

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009