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SD Cystic Fibrosis Study

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SB656933

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Lung function, Anti-Inflammatory

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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cannot be withdrawn from oral azithromycin during study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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

50 mg treatment

150 mg treatment

Outcomes

Primary Outcome Measures

Blood samples

Secondary Outcome Measures

Safety: ECG, vital signs, clinical labs

Continuous adverse event monitoring

Full Information

NCT ID

NCT00605761

First Posted

January 18, 2008

Last Updated

March 15, 2012

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00605761

Brief Title

SD Cystic Fibrosis Study

Official Title

An Open Label Dose Ascending, Single Dose Study to Investigate the Pharmacokinetics of SB-656933 in Subjects With Cystic Fibrosis.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis, Lung function, Anti-Inflammatory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

50 mg treatment

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

150 mg treatment

Intervention Type

Drug

Intervention Name(s)

SB656933

Intervention Description

50 mg treatment

Intervention Type

Drug

Intervention Name(s)

SB656933

Intervention Description

150 mg treatment

Primary Outcome Measure Information:

Title

Blood samples

Time Frame

over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933

Secondary Outcome Measure Information:

Title

Safety: ECG, vital signs, clinical labs

Time Frame

over 48hours post SB656933 dosing in both dosing sessions

Title

Continuous adverse event monitoring

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

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SD Cystic Fibrosis Study

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