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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01611805




Registration number
NCT01611805
Ethics application status
Date submitted
12/04/2012
Date registered
5/06/2012
Date last updated
14/06/2017

Titles & IDs
Public title
Japanese Phase I of GSK1605786
Scientific title
A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject
Secondary ID [1] 0 0
114472
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1605786
Treatment: Drugs - GSK1605786 Placebo

Experimental: GSK1605786 250mg - Opaque Swedish orange body and cap.

Placebo Comparator: Placebo - Opaque Swedish orange body and cap.

Experimental: GSK1605786 500mg - Opaque Swedish orange body and cap.

Experimental: GSK1605786 1000mg - Opaque Swedish orange body and cap.

Experimental: GSK1605786 500mg in fed - Opaque Swedish orange body and cap.


Treatment: Drugs: GSK1605786
Opaque Swedish orange body and cap.

Treatment: Drugs: GSK1605786 Placebo
Opaque Swedish orange body and cap.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma concentration
Timepoint [1] 0 0
up to 72h post dose
Secondary outcome [1] 0 0
Adverse envents
Timepoint [1] 0 0
up to 72h post dose
Secondary outcome [2] 0 0
Vital signe
Timepoint [2] 0 0
up to 72h post dose
Secondary outcome [3] 0 0
Clinical laboratory
Timepoint [3] 0 0
up to 72h post dose
Secondary outcome [4] 0 0
12 lead ECG
Timepoint [4] 0 0
up to 72h post dose

Eligibility
Key inclusion criteria
- Healthy Japanese as

- Japanese defined as being born in Japan, having four ethnic Japanese grandparents,
holding a Japanese passport or identity -Male between 20 and 55 years of age
inclusive, at the time of signing the informed consent.

- Body weight =>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive).
Minimum age
20 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to
screen for undiagnosed celiac disease)

Study design
Purpose of the study
Other
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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 is an double-blind, single dose, four-period, crossover study in Japanese healthy male
volunteers to assess the pharmacokinetics and safety/tolerability of single doses of
GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg
GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose
ascending crossover design. Serial pharmacokinetic samples will be collected following each
dose and safety assessments will be performed. The pharmacokinetics and dose proportionality
of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and
1000 mg under fasted conditions will be assessed. In addition, a comparison will be made
between the pharmacokinetics of GSK1605786 under fed and fasted conditions.
Trial website
https://clinicaltrials.gov/show/NCT01611805
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