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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01424462




Registration number
NCT01424462
Ethics application status
Date submitted
14/04/2011
Date registered
29/08/2011
Date last updated
20/06/2017

Titles & IDs
Public title
Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.
Scientific title
An Open Label, Randomised Healthy Volunteer Study to Assess the Single Dose Safety and Pharmacokinetics of Three Modified Release Dosage Forms of Firategrast
Secondary ID [1] 0 0
114107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - A
Treatment: Drugs - B
Treatment: Drugs - C
Treatment: Drugs - D

Experimental: Firategrast XRA - Low extended release tablet

Experimental: Firategrast XRB - Medium extended releast tablet

Experimental: Firategrast XRC - High extended release tablet

Experimental: Firategrast IR - Immediate Release reference tablet


Treatment: Drugs: A
Single dose treatment IR formulation

Treatment: Drugs: B
Low Extended release single dose

Treatment: Drugs: C
Medium extended release formulation

Treatment: Drugs: D
High extended release rate single dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Systemic concentration & AUC of study drug
Timepoint [1] 0 0
pre-dose, up to 120 hours after each single dose
Secondary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
from screening, through study day, and up to follow-up visit. Spontaneous reporting
Secondary outcome [2] 0 0
Systemic concentration & AUC of study drug metabolite
Timepoint [2] 0 0
pre-dose, up to 120 hours after each single dose
Secondary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
screening, pre-dose, up-to 15 hours post does, follow-up visit
Secondary outcome [4] 0 0
12-lead Electrocardiogram
Timepoint [4] 0 0
screening, pre-dose and up to 8 hours post dose, then at follow-up
Secondary outcome [5] 0 0
Heamatology, clinical chemistry and Uninalysis
Timepoint [5] 0 0
screening, predose, up-to 8 hours post dose, follow-up

Eligibility
Key inclusion criteria
- Male or female, aged 18 to 65 yrs inclusive

- Healthy, as determined by study physician

- Capable of giving informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/07/2010
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01424462
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01424462