SD Cystic Fibrosis Study

NCT00605761 | Completed Phase 1

• 1 other identifier: CF2110398
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

Cystic Fibrosis; Lung function; Anti-Inflammatory

Outcome Measures

Primary Outcomes (1)

• Blood samples

  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

  over 48hours post SB656933 dosing in both dosing sessions

• Continuous adverse event monitoring

  from dosing until study conclusion and follow up, 4-7 days after the treatment period

Study Arms (2)

Cohort 1

EXPERIMENTAL

50 mg treatment

Drug: SB656933

Cohort 2

EXPERIMENTAL

150 mg treatment

Drug: SB656933

Interventions

SB656933 DRUG

50 mg treatment

Cohort 1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Palo Alto, California, 94304, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

SB 656933

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 19, 2012

Record last verified: 2011-04

Locations

US (3)