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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Cmax of firategrast
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 - AUC(0-t) of firategrast
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 - AUC(0-24) of firategrast
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 - Adverse events, changes iin blood pressure, heart rate, ECGs, Haematology, clinical chemistry and urinalysis
Timepoint [1] 0 0
Part 1: approx. 4 weeks, Part 2: approx 8 days
Secondary outcome [2] 0 0
CD34 positive cell count - as data permit - exploratory measure
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 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.
Trial website
https://clinicaltrials.gov/show/NCT01416363
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
Other publications