Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424462
• Other study ID #: 114107
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2011
• Last updated: June 19, 2017
• Start date: April 19, 2010
• Est. completion date: July 6, 2010

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 6, 2010
• Est. primary completion date: July 6, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18 to 65 yrs inclusive

• Healthy, as determined by study physician

• Capable of giving informed 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 21 units for males, more than 14 units for females)

• Participation in a clinical trial within 90 days of scheduled first dose

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Drug:
• A
Single dose treatment IR formulation
• B
Low Extended release single dose
• C
Medium extended release formulation
• D
High extended release rate single dose

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic concentration & AUC of study drug		pre-dose, up to 120 hours after each single dose
Secondary	Adverse events		from screening, through study day, and up to follow-up visit. Spontaneous reporting
Secondary	Systemic concentration & AUC of study drug metabolite		pre-dose, up to 120 hours after each single dose
Secondary	Vital signs		screening, pre-dose, up-to 15 hours post does, follow-up visit
Secondary	12-lead Electrocardiogram		screening, pre-dose and up to 8 hours post dose, then at follow-up
Secondary	Heamatology, clinical chemistry and Uninalysis	Blood samples for standard clinical safety monitoring, and unine samples	screening, predose, up-to 8 hours post dose, follow-up

External Links

•   Results for study 114107 can be found on the GSK Clinical Study Register.