Crohn's DiseasePhase 1NCT01114607

A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects

A Phase 1 study testing GSK1605786 ChemoCentryx: formulation A, GSK1605786 GSK: formulation B and GSK1605786 GSK direct-fill: formulation C in people with Crohn's Disease, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCentryx Thorough… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Crohn's Disease
What is being tested?: GSK1605786 ChemoCentryx: formulation A, GSK1605786 GSK: formulation B and GSK1605786 GSK direct-fill: formulation C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 5 May 2010to 29 Jun 2010
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of:
Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 4 weeks post-last dose.

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Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 4 weeks post-last dose.
Body weight ≥ 50 kg (110lbs) for men and ≥45 kg (99 lbs) for women, and BMI within the range 18.5 - 31 kg/m2 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
12-lead ECG without any clinically significant abnormality as judged by the Investigator, and average QTcB or QTcF < 450 msec or QTc < 480 msec in subjects with Bundle Branch Block.
Able to complete all study procedures and planned treatment periods.

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 abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Known celiac disease and positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.
History of regular alcohol consumption within 6 months of the study defined as:

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an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Unwilling to abstain from alcohol for 48 hours prior to screening, and 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
History of sensitivity to the study medication, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Pregnant females as determined by positive serum hCG test at screening or urine hCG test prior to dosing.
Lactating females.
The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg, or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects at Screening and pre-dose on Day 1.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
Subject with a medical condition which in the opinion of the investigator and GSK Medical Monitor makes them unsuitable for the study.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
History of regular use of tobacco- or nicotine-containing products within 6 months prior to screening and unwilling to remain abstinent from tobacco or nicotine containing products for the duration of the study.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pomegranate, and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Buffalo, New York, 14202

Other trials in United States

About this study

Official title: A Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female Subjects

Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.

Read the detailed description

This will be a randomized, open-label, single-dose, five-period, crossover study in healthy volunteers to compare the relative bioavailability of 5 oral GSK1605786 formulations. Recruitment/screening will occur within approximately 30 days of the first scheduled dose of study medication. Each subject will participate in five dosing sessions - each dose will be separated by at least seven days. The total duration of a subject's participation in the study, from Screening to Follow-up, is approximately 10 weeks.

All subjects will receive single 500mg doses of the following five GSK1605786 formulations: A. ChemoCentryx formulation of GSK1605786; 2 x 250mg capsules [Formulation A] B. GSK formulation of GSK1605786; 2 x 250mg capsules [Formulation B] C. GSK direct-fill formulation of GSK1605786; 2 x 250mg capsules [Formulation C] D. GSK modified formulation of GSK1605786; 2 x 250mg capsules [Formulation D] E. GSK tablet formulation of GSK1605786; 500mg tablet [Formulation E]

Formulations A and B will administered in periods 1 and 2 in a random order, and formulations C, D and E will be administered in periods 3, 4, and 5 in a random order.

Subjects will check into the clinical research unit (CRU) 1 day prior to dosing (Day -1). The study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes after a standard breakfast (i.e., fed state). For each treatment period, subjects will stay in the CRU through the 48-hour PK sample on the morning of Day 3. Subjects may be released from the clinic on Day 3 (after all required study procedures are completed) and return to the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples.

Upon completion of the last dosing period or early withdrawal, subjects will return to the clinic approximately seven days after the last dose of study medication for a follow up visit and be subsequently discharged from the study.

The study will be conducted at one center.

Conditions: Crohn's Disease
Being tested: GSK1605786 ChemoCentryx: formulation A, GSK1605786 GSK: formulation B, GSK1605786 GSK direct-fill: formulation C, GSK1605786 GSK modified-process: formulation D, GSK1605786 GSK tablet: formulation E
Keywords: GSK1605786, relative bioavailability, CCR9 receptor antagonist
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 ChemoCentryx: formulation ADrug
ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
GSK1605786 GSK: formulation BDrug
GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK direct-fill: formulation CDrug
GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
GSK1605786 GSK modified-process: formulation DDrug
GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
GSK1605786 GSK tablet: formulation EDrug
GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.

Study groups in NCT01114607
Study group	Role	What they receive
Treatment sequence ABCDE	Experimental	Eligible subjects will be randomized in sequence ABCDE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence ABDEC	Experimental	Eligible subjects will be randomized in sequence ABDEC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence ABECD	Experimental	Eligible subjects will be randomized in sequence ABECD and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence ABCED	Experimental	Eligible subjects will be randomized in sequence ABCED and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= a film coated tablet of GSK1605786 GSK formulation 500 mg once daily and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence ABDCE	Experimental	Eligible subjects will be randomized in sequence ABDCE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence ABEDC	Experimental	Eligible subjects will be randomized in sequence ABEDC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence BACDE	Experimental	Eligible subjects will be randomized in sequence BACDE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence BADEC	Experimental	Eligible subjects will be randomized in sequence BADEC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence BAECD	Experimental	Eligible subjects will be randomized in sequence BAECD and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence BACED	Experimental	Eligible subjects will be randomized in sequence BACED and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence BADCE	Experimental	Eligible subjects will be randomized in sequence BADCE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E
Treatment sequence BAEDC	Experimental	Eligible subjects will be randomized in sequence BAEDC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily. Receives: Drug: GSK1605786 ChemoCentryx: formulation A; Drug: GSK1605786 GSK: formulation B; Drug: GSK1605786 GSK direct-fill: formulation C; Drug: GSK1605786 GSK modified-process: formulation D; Drug: GSK1605786 GSK tablet: formulation E

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma GSK1605786 parameters: AUC(0-∞), AUC(0-t), Cmax.
Measured: 2-4 weeks after the last subject last visit

Secondary outcomes (2)

Plasma GSK1605786 parameters: AUC(0-24), %AUCex, tlag, tmax, t1/2
Measured: 2-4 weeks after the last subject last visit
Safety and tolerability parameters including vital signs, ECGs, clinical laboratory
Measured: Results will be monitered in real time from screening through to the follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 201029 Jun 2010

First posted3 May 2010 (estimated)
Study start5 May 2010
Primary completion29 Jun 2010
Study completion29 Jun 2010

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: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01114607
Sponsor's protocol ID: 114203
Status last verified: Jul 2017
First submitted: 29 Apr 2010
Last updated: 18 Jul 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT01114607
Acronym / sponsor ID: 114203
Conditions: Crohn's Disease
Keywords: GSK1605786, relative bioavailability, CCR9 receptor antagonist
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 5 May 2010 (actual)
Primary completion: 29 Jun 2010 (actual)
Study completion: 29 Jun 2010 (actual)
First posted: 3 May 2010 (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.

Detailed description

Formulations A and B will administered in periods 1 and 2 in a random order, and formulations C, D and E will be administered in periods 3, 4, and 5 in a random order.

The study will be conducted at one center.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Treatment sequence ABCDE	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence ABCDE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence ABDEC	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence ABDEC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
Treatment sequence ABECD	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence ABECD and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence ABCED	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence ABCED and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= a film coated tablet of GSK1605786 GSK formulation 500 mg once daily and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence ABDCE	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence ABDCE and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence ABEDC	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence ABEDC and will receive: A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
Treatment sequence BACDE	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence BACDE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence BADEC	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence BADEC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.
Treatment sequence BAECD	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence BAECD and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence BACED	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence BACED and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, and D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily.
Treatment sequence BADCE	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence BADCE and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily, and E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily.
Treatment sequence BAEDC	Experimental	Drug: GSK1605786 ChemoCentryx: formulation A, Drug: GSK1605786 GSK: formulation B, Drug: GSK1605786 GSK direct-fill: formulation C, Drug: GSK1605786 GSK modified-process: formulation D, Drug: GSK1605786 GSK tablet: formulation EEligible subjects will be randomized in sequence BAEDC and will receive: B= two capsules of GSK1605786 GSK formulation 250 milligrams once daily, A= two capsules of GSK1605786 ChemoCentryx formulation 250 milligrams once daily, E= film coated tablet of GSK1605786 GSK formulation 500 mg once daily, D= two capsules of GSK1605786 GSK modified-process formulation 250 milligrams once daily, and C= two capsules of GSK1605786 GSK direct-fill formulation 250 milligrams once daily.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of:
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 4 weeks post-last dose.

Key exclusion criteria (22 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 abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Known celiac disease and positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.

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 ChemoCentryx: formulation AChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.	Drug	Treatment sequence ABCDE, Treatment sequence ABCED, Treatment sequence ABDCE, Treatment sequence ABDEC, Treatment sequence ABECD, Treatment sequence ABEDC, Treatment sequence BACDE, Treatment sequence BACED, Treatment sequence BADCE, Treatment sequence BADEC, Treatment sequence BAECD, Treatment sequence BAEDC
GSK1605786 GSK: formulation BGSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.	Drug	Treatment sequence ABCDE, Treatment sequence ABCED, Treatment sequence ABDCE, Treatment sequence ABDEC, Treatment sequence ABECD, Treatment sequence ABEDC, Treatment sequence BACDE, Treatment sequence BACED, Treatment sequence BADCE, Treatment sequence BADEC, Treatment sequence BAECD, Treatment sequence BAEDC
GSK1605786 GSK direct-fill: formulation CGSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.	Drug	Treatment sequence ABCDE, Treatment sequence ABCED, Treatment sequence ABDCE, Treatment sequence ABDEC, Treatment sequence ABECD, Treatment sequence ABEDC, Treatment sequence BACDE, Treatment sequence BACED, Treatment sequence BADCE, Treatment sequence BADEC, Treatment sequence BAECD, Treatment sequence BAEDC
GSK1605786 GSK modified-process: formulation DGSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.	Drug	Treatment sequence ABCDE, Treatment sequence ABCED, Treatment sequence ABDCE, Treatment sequence ABDEC, Treatment sequence ABECD, Treatment sequence ABEDC, Treatment sequence BACDE, Treatment sequence BACED, Treatment sequence BADCE, Treatment sequence BADEC, Treatment sequence BAECD, Treatment sequence BAEDC
GSK1605786 GSK tablet: formulation EGSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.	Drug	Treatment sequence ABCDE, Treatment sequence ABCED, Treatment sequence ABDCE, Treatment sequence ABDEC, Treatment sequence ABECD, Treatment sequence ABEDC, Treatment sequence BACDE, Treatment sequence BACED, Treatment sequence BADCE, Treatment sequence BADEC, Treatment sequence BAECD, Treatment sequence BAEDC

Primary outcome

Plasma GSK1605786 parameters: AUC(0-∞), AUC(0-t), Cmax.
Time frame: 2-4 weeks after the last subject last visit

2 secondary outcomes

Plasma GSK1605786 parameters: AUC(0-24), %AUCex, tlag, tmax, t1/2
Time frame: 2-4 weeks after the last subject last visit
Safety and tolerability parameters including vital signs, ECGs, clinical laboratory
Time frame: Results will be monitered in real time from screening through to the follow-up visit

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 18 Jul 2017.
Results for study 114203 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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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?

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 11 inclusion and 22 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 18 Jul 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 United States. 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?

Plasma GSK1605786 parameters: AUC(0-∞), AUC(0-t), Cmax. (time frame: 2-4 weeks after the last subject last visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01114607.

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 18 Jul 2017.