Multiple Sclerosis, Relapsing-RemittingPhase 1NCT01416363
Healthy Volunteer Study Using 3 Different Formulations of Firategrast
A Phase 1 study testing Firategrast immediate release tablet, Firategrast modified release tablet and Firategrast gastro-retentive solution in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
This study will investigate how 3 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 is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Firategrast immediate release tablet, Firategrast modified release tablet and Firategrast gastro-retentive solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 20 May 2011to 17 Sep 2011
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving iformed 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 12 units for males)
- Participation in a clinical trial within 30 days of scheduled first dose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male Volunteers
This study will investigate how 3 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 is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. 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 a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.
Read the detailed description
The present study will be conducted in two parts in healthy male volunteers. Part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as a simulated gastro-retentive formulation to be administered via a naso-gastric tube. Subjects will receive each formulation in a randomised 3-way single dose crossover fashion.
Part 2, based on the review of safety, tolerability and pharmacokinetic data from the first two study treatment periods of Part 1, will investigate the pharmacokinetics and tolerability of multiple doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive formulation to be administered via naso-gastric tube for a period of 7 days.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Firategrast immediate release tablet, Firategrast modified release tablet, Firategrast gastro-retentive solution
- Keywords
- firategrast, pharmacokinetics, modified release, firategrast,, simulated gastro-retentive, pharmacokinetics, healthy volunteers, simulated gastro-retentive, healthy volunteers, 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.
Firategrast immediate release tabletDrug
Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
Firategrast modified release tabletDrug
Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
Firategrast gastro-retentive solutionDrug
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm ACB: Part 1 | Experimental | Subjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm BAC: Part 1 | Experimental | Subjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses. Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm CBA: Part 1 | Experimental | Subjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm BCA: Part 1 | Experimental | Subjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm CAB: Part 1 | Experimental | Subjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm ABC: Part 1 | Experimental | Subjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses. Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm D: Part 2 | Experimental | Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm E: Part 2 | Experimental | Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
| Treatment Arm F: Part 2 | Experimental | Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days Receives: Drug: Firategrast immediate release tablet; Drug: Firategrast modified release tablet; Drug: Firategrast gastro-retentive solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic measures for single and repeat dose
Cmax of firategrast
Measured: Part 1: approx. 4 weeks, Part 2: approx 8 days
PK measures for single and repeat dose
AUC(0-t) of firategrast
Measured: Part 1 approx 4 weeks, Part 2 approx 8 days
Pharmacokinetic measurements for single and repeat dose
AUC(0-24) of firategrast
Measured: Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary outcomes (2)
Safety & Tolerability in single and repeat doses
Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis
Measured: Part 1: approx. 4 weeks, Part 2: approx 8 days
CD34 positive cell count
as data permit - exploratory measure
Measured: Part 1 only approx 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start20 May 2011
- Primary completion17 Sep 2011
- Study completion17 Sep 2011
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
- 38 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
- NCT01416363
- Sponsor's protocol ID
- 115517
- Status last verified
- Jul 2017
- First submitted
- 23 Jun 2011
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01416363
- Acronym / sponsor ID
- 115517
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- firategrast, pharmacokinetics, modified release, firategrast,, simulated gastro-retentive, pharmacokinetics, healthy volunteers, simulated gastro-retentive, healthy volunteers, modified release
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 May 2011 (actual)
- Primary completion
- 17 Sep 2011 (actual)
- Study completion
- 17 Sep 2011 (actual)
- First posted
- 15 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 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 is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. 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 a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.
Detailed description
The present study will be conducted in two parts in healthy male volunteers. Part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as a simulated gastro-retentive formulation to be administered via a naso-gastric tube. Subjects will receive each formulation in a randomised 3-way single dose crossover fashion.
Part 2, based on the review of safety, tolerability and pharmacokinetic data from the first two study treatment periods of Part 1, will investigate the pharmacokinetics and tolerability of multiple doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive formulation to be administered via naso-gastric tube for a period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm ACB: Part 1 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm BAC: Part 1 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses. |
| Treatment Arm CBA: Part 1 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm BCA: Part 1 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm CAB: Part 1 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm ABC: Part 1 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses. |
| Treatment Arm D: Part 2 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days |
| Treatment Arm E: Part 2 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days |
| Treatment Arm F: Part 2 | Experimental | Drug: Firategrast immediate release tablet, Drug: Firategrast modified release tablet, Drug: Firategrast gastro-retentive solutionSubject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving iformed 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 12 units for males)
- Participation in a clinical trial within 30 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 |
|---|---|---|
| Firategrast immediate release tabletFirategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water. | Drug | Treatment Arm ABC: Part 1, Treatment Arm ACB: Part 1, Treatment Arm BAC: Part 1, Treatment Arm BCA: Part 1, Treatment Arm CAB: Part 1, Treatment Arm CBA: Part 1, Treatment Arm D: Part 2, Treatment Arm E: Part 2, Treatment Arm F: Part 2 |
| Firategrast modified release tabletFirategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water. | Drug | Treatment Arm ABC: Part 1, Treatment Arm ACB: Part 1, Treatment Arm BAC: Part 1, Treatment Arm BCA: Part 1, Treatment Arm CAB: Part 1, Treatment Arm CBA: Part 1, Treatment Arm D: Part 2, Treatment Arm E: Part 2, Treatment Arm F: Part 2 |
| Firategrast gastro-retentive solutionFirategrast solution is clear colorless solution and subject will administer it via nasogastric route. | Drug | Treatment Arm ABC: Part 1, Treatment Arm ACB: Part 1, Treatment Arm BAC: Part 1, Treatment Arm BCA: Part 1, Treatment Arm CAB: Part 1, Treatment Arm CBA: Part 1, Treatment Arm D: Part 2, Treatment Arm E: Part 2, Treatment Arm F: Part 2 |
Primary outcome
Pharmacokinetic measures for single and repeat dose
Time frame: Part 1: approx. 4 weeks, Part 2: approx 8 days
Cmax of firategrast
PK measures for single and repeat dose
Time frame: Part 1 approx 4 weeks, Part 2 approx 8 days
AUC(0-t) of firategrast
Pharmacokinetic measurements for single and repeat dose
Time frame: Part 1: approx 4 weeks, Part 2: approx 8 days
AUC(0-24) of firategrast
2 secondary outcomes
Safety & Tolerability in single and repeat doses
Time frame: Part 1: approx. 4 weeks, Part 2: approx 8 days
CD34 positive cell count
Time frame: Part 1 only approx 4 weeks
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 7 Jul 2017.
- Results for study 115517 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 Firategrast immediate release tablet, Firategrast modified release tablet and Firategrast gastro-retentive solution 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 7 Jul 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?
Pharmacokinetic measures for single and repeat dose (time frame: Part 1: approx. 4 weeks, Part 2: approx 8 days). The study lists 3 primary outcomes in all. 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 7 Jul 2017.