Multiple SclerosisPhase 1NCT00548769
Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients
A Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Multiple Sclerosis, run by GlaxoSmithKline at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Formulation A, Formulation B and Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Apr 2007to 26 Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Poland2 sites
GSK Investigational Site
Grodzisk Mazowiecki, 05-825
GSK Investigational Site
Poznan, 60-479
About this study
Official title: 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
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- Formulation A, Formulation B, Formulation C, Formulation D
- Keywords
- PK,, SB-683699,, multiple sclerosis, firategrast,, surface area,
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation ADrug
Also called firategrast (SB683699)
Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water.
Formulation BDrug
Formulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
Formulation CDrug
Formulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water.
Formulation DDrug
Formulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water.
| Study group | Role | What they receive |
|---|---|---|
| Sequence ADBC | Experimental | Subjects will be administered formulation A, formulation D, formulation B and formulation C across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D |
| Sequence BACD | Experimental | Subjects will be administered formulation B, formulation A, formulation C and formulation D across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D |
| Sequence CBDA | Experimental | Subjects will be administered formulation C, formulation B, formulation D and formulation A across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D |
| Sequence DCAB | Experimental | Subjects will be administered formulation D, formulation C, formulation A and formulation B across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The AUC(0-24) for firategrast following administration of tablets made from three different batches of drug with different surface areas.
Measured: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose
Secondary outcomes (3)
Cmax and Tmax. The AUC(0-24) Cmax and Tmax of of SB683699 metabolite GW786375X.
Measured: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose
AEs, vital signs and clinical laboratory data during the course of the study.
Measured: Throughout the course of the study
SB-683699 and GW786375X plasma concentration to derive pharmacokinetic parameters.
Measured: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study start21 Apr 2007
- Primary completion26 Nov 2007
- Study completion26 Nov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548769
- Sponsor's protocol ID
- A4M109079
- Status last verified
- Jul 2017
- First submitted
- 23 Oct 2007
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00548769
- Acronym / sponsor ID
- A4M109079
- Conditions
- Multiple Sclerosis
- Keywords
- PK,, SB-683699,, multiple sclerosis, firategrast,, surface area,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2007 (actual)
- Primary completion
- 26 Nov 2007 (actual)
- Study completion
- 26 Nov 2007 (actual)
- First posted
- 24 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence ADBC | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation DSubjects will be administered formulation A, formulation D, formulation B and formulation C across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. |
| Sequence BACD | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation DSubjects will be administered formulation B, formulation A, formulation C and formulation D across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. |
| Sequence CBDA | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation DSubjects will be administered formulation C, formulation B, formulation D and formulation A across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. |
| Sequence DCAB | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation DSubjects will be administered formulation D, formulation C, formulation A and formulation B across four study days each separated by a washout period of at least seven days. Subjects will fast overnight prior to dosing. Blood samples will be collected at intervals over a period of 24 hours post-dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation AAlso: firategrast (SB683699)Formulation A will contain firategrast drug substance from native drug batch Irvine. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.1 square meter per gram. The tablets will be administered with 240 milliliters of water. | Drug | Sequence ADBC, Sequence BACD, Sequence CBDA, Sequence DCAB |
| Formulation BFormulation B will contain firategrast drug substance from native drug batch Tonbridge. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water. | Drug | Sequence ADBC, Sequence BACD, Sequence CBDA, Sequence DCAB |
| Formulation CFormulation C will contain firategrast drug substance from Tonbridge single pass micronized drug. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 3-4 square meter per gram. The tablets will be administered with 240 milliliters of water. | Drug | Sequence ADBC, Sequence BACD, Sequence CBDA, Sequence DCAB |
| Formulation DFormulation D will contain firategrast drug substance from Tonbridge with reduced tablet size. Subjects will be administered three tablets of 300 milligrams with drug substance surface area of 2.6 square meter per gram. The tablets will be administered with 240 milliliters of water. | Drug | Sequence ADBC, Sequence BACD, Sequence CBDA, Sequence DCAB |
Primary outcome
The AUC(0-24) for firategrast following administration of tablets made from three different batches of drug with different surface areas.
Time frame: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose
3 secondary outcomes
Cmax and Tmax. The AUC(0-24) Cmax and Tmax of of SB683699 metabolite GW786375X.
Time frame: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours 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.
Time frame: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Results for study 109079 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Multiple Sclerosis, run by GlaxoSmithKline at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AUC(0-24) for firategrast following administration of tablets made from three different batches of drug with different surface areas. (time frame: Pre-dose. 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.