Healthy Volunteer Study Using 3 Different Formulations of Firategrast
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: A Drug: B Drug: C Drug: D Drug: E Drug: F |
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: | 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 |
- Pharmacokinetic measures for single and repeat dose [ Time Frame: Part 1: approx. 4 weeks, Part 2: approx 8 days ] [ Designated as safety issue: No ]Cmax of firategrast
- PK measures for single and repeat dose [ Time Frame: Part 1 approx 4 weeks, Part 2 approx 8 days ] [ Designated as safety issue: No ]AUC(0-t) of firategrast
- Pharmacokinetic measurements for single and repeat dose [ Time Frame: Part 1: approx 4 weeks, Part 2: approx 8 days ] [ Designated as safety issue: No ]AUC(0-24) of firategrast
- Safety & Tolerability in single and repeat doses [ Time Frame: Part 1: approx. 4 weeks, Part 2: approx 8 days ] [ Designated as safety issue: No ]Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis
- CD34 positive cell count [ Time Frame: Part 1 only approx 4 weeks ] [ Designated as safety issue: No ]as data permit - exploratory measure
| Enrollment: | 38 |
| Study Start Date: | May 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Firategrast immediate release tablet |
Drug: A
Single dose Firategrast immediate release formulation
Drug: D
Repeat dose Firategrast immediate release formulation
|
| Experimental: Firategrast modified release tablet |
Drug: B
Single dose Firategrast modified release formulation
Drug: E
Repeat dose Firategrast modified release formulation
|
| Experimental: Firategrast gastro-retentive solution |
Drug: C
Single dose Firategrast simulated gastro-retentive formulation
Drug: F
Repeat dose Firategrast simulated gastro-retentive formulation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male aged 18 to 65 yrs inclusive
- Healthy, as determined by study physician
- Capable of giving iformed consent
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01416363 History of Changes |
| Other Study ID Numbers: | 115517 |
| Study First Received: | June 23, 2011 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Food and Drug Administration Australia: Therapeutic Goods Administration |
Keywords provided by GlaxoSmithKline:
|
firategrast pharmacokinetics, modified release, firategrast, simulated gastro-retentive pharmacokinetics |
healthy volunteers, simulated gastro-retentive healthy volunteers modified release |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013