Multiple Sclerosis, Relapsing-RemittingPhase 1NCT01424462
Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.
A Phase 1 study testing A, B and C in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
This study will investigate how 3 new types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- A, B and C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Apr 2010to 6 Jul 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving informed consent
Who cannot join
- Positive drugs of abuse result
- Positive for HIV or Hepatitis B and/or C viruses
- History of alcohol consumption in excess of average recommended weekly intake (more than 21 units for males, more than 14 units for females)
- Participation in a clinical trial within 90 days of scheduled first dose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
This study will investigate how 3 new types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study involves all volunteers receiving all 3 different formulations, as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.
Read the detailed description
The present study will investigate the tolerability and pharmacokinetics of single oral doses of firategrast administered as the existing immediate release tablet formulation and as three modified release tablet formulations designed to release drug over differing relase rates. The range of release rates is expected to give preliminary information on the performance of a matrix modified release formulation for use in future efficacy studies.
Subjects will receive each formulation in the fasted state in a randomised 4-part single dose crossover fashion. Based on the review of pharmacokinetic data from at least the first two study sessions, subjects may also receive a fifth dose of firategrast, administered after a high fat meal. The formulation administered with food will be chosen based upon pharmacokinetic data from previous dose sessions. Doses administered will be different with respect to gender; the doses are expected to result in similar exposures across the genders.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- A, B, C, D
- Keywords
- healthy volunteers, firategrast, Pharmacokinetics, modified release
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADrug
Single dose treatment IR formulation
BDrug
Low Extended release single dose
CDrug
Medium extended release formulation
DDrug
High extended release rate single dose
| Study group | Role | What they receive |
|---|---|---|
| Firategrast XRA | Experimental | Low extended release tablet Receives: Drug: B |
| Firategrast XRB | Experimental | Medium extended releast tablet Receives: Drug: C |
| Firategrast XRC | Experimental | High extended release tablet Receives: Drug: D |
| Firategrast IR | Experimental | Immediate Release reference tablet Receives: Drug: A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic concentration & AUC of study drug
Measured: pre-dose, up to 120 hours after each single dose
Secondary outcomes (5)
Adverse events
Measured: from screening, through study day, and up to follow-up visit. Spontaneous reporting
Systemic concentration & AUC of study drug metabolite
Measured: pre-dose, up to 120 hours after each single dose
Vital signs
Measured: screening, pre-dose, up-to 15 hours post does, follow-up visit
12-lead Electrocardiogram
Measured: screening, pre-dose and up to 8 hours post dose, then at follow-up
Heamatology, clinical chemistry and Uninalysis
Blood samples for standard clinical safety monitoring, and unine samples
Measured: screening, predose, up-to 8 hours post dose, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study start19 Apr 2010
- Primary completion6 Jul 2010
- Study completion6 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- 20 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
- NCT01424462
- Sponsor's protocol ID
- 114107
- Status last verified
- Jun 2017
- First submitted
- 14 Apr 2011
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
- ClinicalTrials.gov ID
- NCT01424462
- Acronym / sponsor ID
- 114107
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- healthy volunteers, firategrast, Pharmacokinetics, modified release
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2010 (actual)
- Primary completion
- 6 Jul 2010 (actual)
- Study completion
- 6 Jul 2010 (actual)
- First posted
- 29 Aug 2011 (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.
This study will investigate how 3 new types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study involves all volunteers receiving all 3 different formulations, as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.
Detailed description
The present study will investigate the tolerability and pharmacokinetics of single oral doses of firategrast administered as the existing immediate release tablet formulation and as three modified release tablet formulations designed to release drug over differing relase rates. The range of release rates is expected to give preliminary information on the performance of a matrix modified release formulation for use in future efficacy studies.
Subjects will receive each formulation in the fasted state in a randomised 4-part single dose crossover fashion. Based on the review of pharmacokinetic data from at least the first two study sessions, subjects may also receive a fifth dose of firategrast, administered after a high fat meal. The formulation administered with food will be chosen based upon pharmacokinetic data from previous dose sessions. Doses administered will be different with respect to gender; the doses are expected to result in similar exposures across the genders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Firategrast XRA | Experimental | Drug: BLow extended release tablet |
| Firategrast XRB | Experimental | Drug: CMedium extended releast tablet |
| Firategrast XRC | Experimental | Drug: DHigh extended release tablet |
| Firategrast IR | Experimental | Drug: AImmediate Release reference tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving informed consent
Key exclusion criteria (4 listed)
- Positive drugs of abuse result
- Positive for HIV or Hepatitis B and/or C viruses
- History of alcohol consumption in excess of average recommended weekly intake (more than 21 units for males, more than 14 units for females)
- Participation in a clinical trial within 90 days of scheduled first dose
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 |
|---|---|---|
| ASingle dose treatment IR formulation | Drug | Firategrast IR |
| BLow Extended release single dose | Drug | Firategrast XRA |
| CMedium extended release formulation | Drug | Firategrast XRB |
| DHigh extended release rate single dose | Drug | Firategrast XRC |
Primary outcome
Systemic concentration & AUC of study drug
Time frame: pre-dose, up to 120 hours after each single dose
5 secondary outcomes
Adverse events
Time frame: from screening, through study day, and up to follow-up visit. Spontaneous reporting
Systemic concentration & AUC of study drug metabolite
Time frame: pre-dose, up to 120 hours after each single dose
Vital signs
Time frame: screening, pre-dose, up-to 15 hours post does, follow-up visit
12-lead Electrocardiogram
Time frame: screening, pre-dose and up to 8 hours post dose, then at follow-up
Heamatology, clinical chemistry and Uninalysis
Time frame: screening, predose, up-to 8 hours post dose, follow-up
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 20 Jun 2017.
- Results for study 114107 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A, B and C in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 1 site in Australia.
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 3 inclusion and 4 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Systemic concentration & AUC of study drug (time frame: pre-dose, up to 120 hours after each single 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 20 Jun 2017.