Healthy Volunteer Study Using 3 Different Formulations of Firategrast

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416363
• Other study ID #: 115517
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2011
• Last updated: July 5, 2017
• Start date: May 20, 2011
• Est. completion date: September 17, 2011

Study information

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

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 17, 2011
• Est. primary completion date: September 17, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Drug:
• Firategrast immediate release tablet
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 tablet
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 solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.

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	Pharmacokinetic measures for single and repeat dose	Cmax of firategrast	Part 1: approx. 4 weeks, Part 2: approx 8 days
Primary	PK measures for single and repeat dose	AUC(0-t) of firategrast	Part 1 approx 4 weeks, Part 2 approx 8 days
Primary	Pharmacokinetic measurements for single and repeat dose	AUC(0-24) of firategrast	Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary	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
Secondary	CD34 positive cell count	as data permit - exploratory measure	Part 1 only approx 4 weeks

External Links

•   Results for study 115517 can be found on the GSK Clinical Study Register.