Crohn's DiseasePhase 1NCT01827631
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
A Phase 1 study testing GSK1605786 capsule in people with Crohn's Disease, run by GlaxoSmithKline at 1 site in China.
Trial summary
This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- GSK1605786 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2013to 25 Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
- Male or female between 18 and 45 years of age
- Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary
- A positive test for HIV antibody at screening
- Known coeliac disease and positive serologic testing for anti-tTG antibodies
- A positive pre-study drug/alcohol screen
- Lactating females
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
- Conditions
- Crohn's Disease
- Being tested
- GSK1605786 capsule
- Keywords
- healthy, GSK1605786, CCR9 receptor antagonist, Chinese subjects, pharmacokinetics
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1605786 capsuleDrug
Swedish Orange, size 0, hard gelatine capsules
| Study group | Role | What they receive |
|---|---|---|
| GSK1605786 500 mg once daily | Experimental | GSK1605786 500 mg is given once daily in the morning Receives: Drug: GSK1605786 capsule |
| GSK1605786 500 mg twice daily | Experimental | GSK1605786 500 mg is given twice daily in the morning and in the evening Receives: Drug: GSK1605786 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum concentration after single dose and repeat dose
Measured: up to 72 hour post dose
AUC(0-τ)
area under the concentration time curve during steady state
Measured: up to 24 hour post last dose
Secondary outcomes (3)
adverse events (AEs)
AEs occur during the study
Measured: up to 21 days, from the first dose until the follow-up visit
vital signs
blood pressure, pulse rate, respiratory rate and temperature
Measured: before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic
lab assessment
Hematology/Clinical Chemistry/Urinalysis test
Measured: Day 17 prior to leaving the clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study start27 May 2013
- Primary completion14 Jun 2013
- Study completion25 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827631
- Sponsor's protocol ID
- 116416
- Status last verified
- Jun 2017
- First submitted
- 5 Apr 2013
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01827631
- Acronym / sponsor ID
- 116416
- Conditions
- Crohn's Disease
- Keywords
- healthy, GSK1605786, CCR9 receptor antagonist, Chinese subjects, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 May 2013 (actual)
- Primary completion
- 14 Jun 2013 (actual)
- Study completion
- 25 Jun 2013 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK1605786 500 mg once daily | Experimental | Drug: GSK1605786 capsuleGSK1605786 500 mg is given once daily in the morning |
| GSK1605786 500 mg twice daily | Experimental | Drug: GSK1605786 capsuleGSK1605786 500 mg is given twice daily in the morning and in the evening |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
- Male or female between 18 and 45 years of age
- Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2
Key exclusion criteria (6 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary
- A positive test for HIV antibody at screening
- Known coeliac disease and positive serologic testing for anti-tTG antibodies
- A positive pre-study drug/alcohol screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1605786 capsuleSwedish Orange, size 0, hard gelatine capsules | Drug | GSK1605786 500 mg once daily, GSK1605786 500 mg twice daily |
Primary outcome
Cmax
Time frame: up to 72 hour post dose
maximum concentration after single dose and repeat dose
AUC(0-τ)
Time frame: up to 24 hour post last dose
area under the concentration time curve during steady state
3 secondary outcomes
adverse events (AEs)
Time frame: up to 21 days, from the first dose until the follow-up visit
vital signs
Time frame: before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic
lab assessment
Time frame: Day 17 prior to leaving the clinic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 116416 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1605786 capsule in people with Crohn's Disease, run by GlaxoSmithKline at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 72 hour post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.