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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
22/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/10/2010
Sample size
Target
Accrual to date
Final
30
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/NCT01611805