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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Treatment Arm BCA: Part 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firategrast immediate release tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic measures for single and repeat dose | Cmax of firategrast | Part 1: approx. 4 weeks, Part 2: approx 8 days |
| PK measures for single and repeat dose | AUC(0-t) of firategrast | Part 1 approx 4 weeks, Part 2 approx 8 days |
| Pharmacokinetic measurements for single and repeat dose | AUC(0-24) of firategrast | Part 1: approx 4 weeks, Part 2: approx 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & Tolerability in single and repeat doses | Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis | Part 1: approx. 4 weeks, Part 2: approx 8 days |
| CD34 positive cell count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia |
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| Label | URL |
|---|---|
| Results for study 115517 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C585685 | Firategrast |
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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. |
|
| 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. |
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| 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. |
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| Treatment Arm D: Part 2 | Experimental | Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days |
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| Treatment Arm E: Part 2 | Experimental | Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days |
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| Treatment Arm F: Part 2 | Experimental | Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days |
|
| Firategrast modified release tablet | Drug | Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water. |
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| Firategrast gastro-retentive solution | Drug | Firategrast solution is clear colorless solution and subject will administer it via nasogastric route. |
|
as data permit - exploratory measure
| Part 1 only approx 4 weeks |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |