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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01416363




Registration number
NCT01416363
Ethics application status
Date submitted
23/06/2011
Date registered
15/08/2011
Date last updated
7/07/2017

Titles & IDs
Public title
Healthy Volunteer Study Using 3 Different Formulations of Firategrast
Scientific 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
Secondary ID [1] 0 0
115517
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 - Firategrast immediate release tablet
Treatment: Drugs - Firategrast modified release tablet
Treatment: Drugs - Firategrast gastro-retentive solution

Experimental: Treatment Arm ACB: Part 1 - 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.

Experimental: Treatment Arm BAC: Part 1 - 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.

Experimental: Treatment Arm CBA: Part 1 - 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.

Experimental: Treatment Arm BCA: Part 1 - 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.

Experimental: Treatment Arm CAB: Part 1 - 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.

Experimental: Treatment Arm ABC: Part 1 - 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.

Experimental: Treatment Arm D: Part 2 - Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days

Experimental: Treatment Arm E: Part 2 - Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days

Experimental: Treatment Arm F: Part 2 - Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Firategrast gastro-retentive solution
Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic measures for single and repeat dose
Timepoint [1] 0 0
Part 1: approx. 4 weeks, Part 2: approx 8 days
Primary outcome [2] 0 0
PK measures for single and repeat dose
Timepoint [2] 0 0
Part 1 approx 4 weeks, Part 2 approx 8 days
Primary outcome [3] 0 0
Pharmacokinetic measurements for single and repeat dose
Timepoint [3] 0 0
Part 1: approx 4 weeks, Part 2: approx 8 days
Secondary outcome [1] 0 0
Safety & Tolerability in single and repeat doses
Timepoint [1] 0 0
Part 1: approx. 4 weeks, Part 2: approx 8 days
Secondary outcome [2] 0 0
CD34 positive cell count
Timepoint [2] 0 0
Part 1 only approx 4 weeks

Eligibility
Key inclusion criteria
* Male aged 18 to 65 yrs inclusive
* Healthy, as determined by study physician
* Capable of giving iformed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
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 12 units for males)
* Participation in a clinical trial within 30 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
20/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/09/2011
Sample size
Target
Accrual to date
Final
38
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01416363