Nutritional StatusPhase 1NCT01209104

Pharmacokinetics and Safety of GSK1325756 in Elderly Subjects and Adult Subjects of in the Fed and Fasted States and in the Presence of a Proton Pump Inhibitors

A Phase 1 study testing GSK1325756 in people with Nutritional Status, 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

Who is it for?: Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Nutritional Status
What is being tested?: GSK1325756
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 14 Apr 2010to 24 May 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 40 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older 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 cardiac monitoring. 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 and study objectives.
However, subjects taking a stable dose of anti-hypertensive medication for at least 3 months prior to enrollment may be included 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 and study objectives. In all cases, subjects should have a resting BP of 140/90 irrespective of anti-hypertensive medication status.
Subjects taking a stable dose of lipid lowering medications (statins or fibrates) for at least 3 months prior to enrollment may be included 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 and study objectives.
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) more than 40 MlU/ml and estradiol less than 40 pg/ml (less than 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.
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 least 3-months post-last dose of study drug.
Body weight more than or equal to 60 kg (110 lbs) for men and more than or equal to 45 kg (99lbs) for women and BMI within the range 19-32 kg/m2 inclusive.

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Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Willingness to complete all study procedures and complete all planned treatment periods and follow up assessments.
7.12 lead ECG without any clinically significant abnormality as judged by the Investigator, and average QTcB or QTcF less than 450 msec 8.AST and ALT less than 2xULN; alkaline phosphatase and bilirubin less than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).

Who cannot join

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A neutrophil count at screening of less than 2 x 109/L
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 an average weekly intake of more than 14 drinks for males or more than 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.

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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,s compromise subject safety, or interfere with the objectives of the study. All concomitant medications should be queried with the GSK Medical Monitor.
History of sensitivity to any of the study medications, 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 or urine hCG test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Urinary cotinine/ exhaled breath CO levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice 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
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Single-dose, Open, Randomized, Crossover Investigation of Age, Gender, Food-effect and Proton-pump Interaction on the Pharmacokinetics of GSK1325756 in Healthy Adult Subjects and a Single-dose, Double Blind, Parallel-group, Placebo- Controlled Investigation of the Pharmacokinetics of GSK1325756

GSK1325756 is a potent, competitive, selective and reversible CXCR2 receptor antagonist that is being developed as a once-daily oral anti-inflammatory medication for the treatment of chronic obstructive pulmonary disease (COPD). Selective antagonism of the interaction between CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying inflammation in COPD via the inhibition of neutrophil recruitment and activation. The current study explores the effects of age, gender and food (high fat meal) on the pharmacokinetics of GSK1325756.

Because a significant proportion of COPD subjects are prescribed proton pump inhibitors (PPI's) such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease (GERD), it is important to understand the absorption of the current formulation of GSK1325756 in an environment of raised intra-gastric pH as will be encountered in patients taking PPI's. Therefore, this study will also evaluate the impact of the proton pump inhibitor omeprazole on the pharmacokinetics of GSK1325756.

Read the detailed description

Conditions: Nutritional Status
Being tested: GSK1325756
Keywords: omeprazole, proton pump inhibitor, COPD, CXCR2 inhibitor, bioavailability, food-effect
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK1325756Drug
100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets
GSK1325756Drug
100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets

Study groups in NCT01209104
Study group	Role	What they receive
Cohort 1-PK and and safety of GSK1325756 in subjects 40-64y	Experimental	This arm assesses the pharmacokinetics and safety of a single oral ose of 100mg of GSK1325756 administered to subjects in the age range 40y-64y when administered in the fasted state, in the presence of a high-fat meal and in the presence of a proton-pump inhibitor. Receives: Drug: GSK1325756
Cohort 2- PK and safety of GSK1325756 in subjects aged 65y-80y	Experimental	This arm assesses the pharmacokinetics and safety of a single dose of 100mg of GSK1325756 administered to a group of subjects in the 64y-80y age range in the fasted state Receives: Drug: GSK1325756

What is being measured

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

Pharmacokinetic parameters for GSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 in the fed (after a high-fat meal) and fasted states in healthy adult subjects in the age range 40 to 64 y
Measured: 48h of dosing
PK ofGSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 given concomitantly with the final oral dose of 40mg omeprazole on the fifth day of repeat omeprazole dosing in healthy adult subjects 40-64y old
Measured: 48h of dosing
PK parameters for GSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 in the fasted state in healthy adult subjects in the age range 65 to 80 years
Measured: 48h of dosing

Secondary outcomes (1)

Safety and tolerability of GSK1325756 alone in the fed and fasted states, alone and in combination with 40 mg omeprazole, as assessed by vital signs, ECGs, clinical laboratory data, clinical monitoring, and subject reports of adverse events.
Measured: 7-14 days of dosing

Timeline

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

14 Apr 201024 May 2010

First posted27 Sep 2010 (estimated)
Study start14 Apr 2010
Primary completion24 May 2010
Study completion24 May 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nutritional StatusStudies 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: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01209104
Sponsor's protocol ID: 113722
Status last verified: Jun 2017
First submitted: 23 Sep 2010
Last updated: 14 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.

Publications

Miller BE, Mistry S, Smart K, Connolly P, Carpenter DC, Cooray H, Bloomer JC, Tal-Singer R, Lazaar AL. The pharmacokinetics and pharmacodynamics of danirixin (GSK1325756)--a selective CXCR2 antagonist --in healthy adult subjects. BMC Pharmacol Toxicol. 2015 Jun 20;16:18. doi: 10.1186/s40360-015-0017-x.
PubMed 26092545

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?

See locations

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All Nutritional Status trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Open, Randomized, Crossover Investigation of Age, Gender, Food-effect and Proton-pump Interaction on the Pharmacokinetics of GSK1325756 in Healthy Adult Subjects and a Single-dose, Double Blind, Parallel-group, Placebo- Controlled Investigation of the Pharmacokinetics of GSK1325756
ClinicalTrials.gov ID: NCT01209104
Acronym / sponsor ID: 113722
Conditions: Nutritional Status
Keywords: omeprazole, proton pump inhibitor, COPD, CXCR2 inhibitor, bioavailability, food-effect
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Apr 2010 (actual)
Primary completion: 24 May 2010 (actual)
Study completion: 24 May 2010 (actual)
First posted: 27 Sep 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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1-PK and and safety of GSK1325756 in subjects 40-64y	Experimental	Drug: GSK1325756This arm assesses the pharmacokinetics and safety of a single oral ose of 100mg of GSK1325756 administered to subjects in the age range 40y-64y when administered in the fasted state, in the presence of a high-fat meal and in the presence of a proton-pump inhibitor.
Cohort 2- PK and safety of GSK1325756 in subjects aged 65y-80y	Experimental	Drug: GSK1325756This arm assesses the pharmacokinetics and safety of a single dose of 100mg of GSK1325756 administered to a group of subjects in the 64y-80y age range in the fasted state

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 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 and study objectives.
However, subjects taking a stable dose of anti-hypertensive medication for at least 3 months prior to enrollment may be included 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 and study objectives. In all cases, subjects should have a resting BP of 140/90 irrespective of anti-hypertensive medication status.
Subjects taking a stable dose of lipid lowering medications (statins or fibrates) for at least 3 months prior to enrollment may be included 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 and study objectives.
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) more than 40 MlU/ml and estradiol less than 40 pg/ml (less than 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.
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 least 3-months post-last dose of study drug.

Key exclusion criteria (18 listed)

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A neutrophil count at screening of less than 2 x 109/L
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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
GSK1325756100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets	Drug	Cohort 1-PK and and safety of GSK1325756 in subjects 40-64y
GSK1325756100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets	Drug	Cohort 2- PK and safety of GSK1325756 in subjects aged 65y-80y

Primary outcome

Pharmacokinetic parameters for GSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 in the fed (after a high-fat meal) and fasted states in healthy adult subjects in the age range 40 to 64 y
Time frame: 48h of dosing
PK ofGSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 given concomitantly with the final oral dose of 40mg omeprazole on the fifth day of repeat omeprazole dosing in healthy adult subjects 40-64y old
Time frame: 48h of dosing
PK parameters for GSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 in the fasted state in healthy adult subjects in the age range 65 to 80 years
Time frame: 48h of dosing

1 secondary outcome

Safety and tolerability of GSK1325756 alone in the fed and fasted states, alone and in combination with 40 mg omeprazole, as assessed by vital signs, ECGs, clinical laboratory data, clinical monitoring, and subject reports of adverse events.
Time frame: 7-14 days of dosing

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 14 Jun 2017.
Derived from this study: PubMed 26092545Miller BE, Mistry S, Smart K, Connolly P, Carpenter DC, Cooray H, Bloomer JC, Tal-Singer R, Lazaar AL. The pharmacokinetics and pharmacodynamics of danirixin (GSK1325756)--a selective CXCR2 antagonist --in healthy adult subjects. BMC Pharmacol Toxicol. 2015 Jun 20;16:18. doi: 10.1186/s40360-015-0017-x.
Results for study 113722 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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.
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 GSK1325756 in people with Nutritional Status, run by GlaxoSmithKline at 1 site in United States.

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 9 inclusion and 18 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 14 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 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?

Pharmacokinetic parameters for GSK1325756 following the administration of a single dose of 100mg of a tablet formulation of GSK1325756 in the fed (after a high-fat meal) and fasted states in healthy adult subjects in the age range 40 to 64 y (time frame: 48h of dosing). The study lists 3 primary outcomes in all. 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 NCT01209104, which also lists 1 linked publication.

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 14 Jun 2017.