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Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00548769
First received: October 23, 2007
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

Sufficient subjects with a confirmed diagnosis of MS (EDSS score of 6.5 or below), will be recruited to ensure that 30 subjects (approx. equal numbers of each gender) complete the study. Subjects will undergo a screening visit, then four study days, each separated by a washout period of at least 7 days, when the different firategrast batches of drug substance will be administered, and a follow-up visit.


Condition Intervention Phase
Multiple Sclerosis
Drug: firategrast (SB683699)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The AUC(0-24) for firategrast following administration of tablets made from three different batches of drug with different surface areas. [ Time Frame: PK samples taken 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h post dose. ]

Secondary Outcome Measures:
  • Cmax and Tmax. The AUC(0-24) Cmax and Tmax of of SB683699 metabolite GW786375X. [ Time Frame: Pk samples taken 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h post dose ]
  • AEs, vital signs and clinical laboratory data during the course of the study. [ Time Frame: Throughout the course of the study ]
  • SB-683699 and GW786375X plasma concentration to derive pharmacokinetic parameters.

Enrollment: 37
Study Start Date: April 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: firategrast (SB683699)
    Other Name: firategrast (SB683699)
Detailed Description:

An open-label, randomised, four period crossover study to investigate the relative pharmacokinetic profiles of tablets from three batches of firategrast with different surface areas and two different tablet formulations containing the same batch of firategrast, given as single 900mg doses to male and female subjects with a diagnosis of Multiple Sclerosis

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 18-65 years inclusive with a diagnosis of MS
  • EDSS between 0-6.5 inclusive at the Screening visit
  • QTc <450msec
  • A female subject is eligible to enter the study if she is of non-childbearing potential, or of childbearing potential, has a negative urine pregnancy test at Screening, and agrees to consistent and correct use of adequate contraception
  • Provide a signed and dated written informed consent prior to study participation
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
  • A negative urine drugs of abuse test.
  • No evidence of pulmonary tuberculosis as verified by a negative chest X-ray within the past 6 months

Exclusion Criteria:

  • Subjects receiving corticosteroids within 4 weeks of Screening for treatment of MS. If non-systemic steroids are being used for other chronic inflammatory conditions, subjects may be included at the discretion of the investigator after discussion with the GSK medical monitor.
  • Use of an β-interferon product, glatiramer acetate or azathioprine within 3 months of Screening, or use of Mitoxantrone within 12 months of Screening. Subjects who have received other therapies affecting the immune system (such as IVIg, cyclophosphamide, plasmapheresis, or any other immunosuppressive or immunomodulatory treatment) in the past may be included on a case by case basis after discussion with the GSK medical monitor. None of these treatments will be allowed during this study
  • Previous exposure to alemtuzumab, natalizumab or bone marrow transplantation or whole body irradiation.
  • Subjects with a cardiac pacemaker or any other type of metal implant or with any other contraindication for MRI (including known allergy to gadolinium).
  • Use of 4-aminopyridine, rosiglitazone, pioglitazone and any other compounds metabolised primarily through cytochrome P450 2C8 are prohibited at Screening and throughout the study
  • Subjects with clinically significant renal laboratory values: subjects with a calculated creatinine clearance <60ml/min
  • Subjects with local urinalysis findings outside of ranges defined in the protocol during the screening period.
  • Presence of clinically significant hepatic laboratory values
  • CD4 count <500 cells/µl, CD4:CD8 <1.0, idiopathic CD4/CD8 lymphopenia or secondary lymphopenia at Screening.
  • JCV DNA detected in plasma or buffy coat using PCR
  • Any findings on the MRI of the brain other than MS, except for benign findings that require no further evaluation or treatment and do not have an impact on the patient's neurological health
  • Current or history of cancer, excluding localized non-melanoma skin cancer.
  • Uncontrolled or any active bacterial, viral, or fungal infection. Any previous serious infections should be discussed with the GSK medical monitor (e.g. opportunistic or atypical infections).
  • History of tuberculosis or positive chest X-ray for TB
  • Known congenital or acquired immunodeficiency.
  • Any abnormality on 12-lead ECG at Screening which is clinically significant in the opinion of the investigator.
  • Subjects with positive hepatitis B, hepatitis C or HIV tests at Screening.
  • Women who are lactating, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the course of the study.
  • Recent history or suspicion of current drug abuse (including analgesic abuse) or alcohol abuse within the last 6 months prior to Screening.
  • Use of an investigational drug for condition other than MS within 30 days or 5 half-lives (whichever is longer) preceding Screening. Prior use of an investigational drug for MS should be discussed with the GSK medical monitor.
  • Any concurrent illness, disability or clinically significant abnormality (including laboratory tests) that may affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548769

Locations
Czech Republic
GSK Investigational Site
Praha 5, Czech Republic, 150 18
Germany
GSK Investigational Site
Berlin, Germany, 10117
Poland
GSK Investigational Site
Grodzisk Mazowiecki, Poland, 05-825
GSK Investigational Site
Poznan, Poland, 60-479
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00548769     History of Changes
Other Study ID Numbers: A4M109079
Study First Received: October 23, 2007
Last Updated: October 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
SB-683699,
firategrast,
PK,
surface area,
multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014