Healthy VolunteerPhase 1DDINCT00858455

A Study to Evaluate the Effect of Antacid and Multivitamin and Mineral Tablet on the Study Drug GSK1349572

A Phase 1 study testing GSK1349572 and MaaloxAdvanced Maximum Strength, GSK1349572 and Maalox Advanced Maximum Strength and GSK1349572 and One A Day in people with Healthy Volunteer, 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 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: GSK1349572 and MaaloxAdvanced Maximum Strength, GSK1349572 and Maalox Advanced Maximum Strength and GSK1349572 and One A Day
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Mar 2009
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Male or female between 18 and 65 years of age.
A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or
Is post-menopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone (FSH) level will be performed to confirm a postmenopausal status. For this study, FSH levels > 40 mlU/ml is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt, HRT should be discontinued for 2 weeks and then the subject rescreened, as HRT can suppress FSH.

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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 14 days after the last dose of study medication.
Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). One repeat measurement to confirm eligibility is allowed.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
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).
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.
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.
If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.

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History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.
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 Hepatitis B surface antigen or positive Hepatitis C antibody result.
A positive test for HIV antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
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. A single repeat to determine eligibility is allowed.
Exclusion criteria for screening ECG as specified in the protocol.

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 Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Maalox® Advanced Maximum Strength and One A Day® Maximum on Pharmacokinetics of GSK1349572 in Healthy Adult Subjects

The purpose is to study the effect of Maalox® and One A Day® on the pharmacokinetics of GSK1349572, and also to compare the safety of GSK1349572 when administered alone and when administered with Maalox® and One A Day®. There are four dosing periods in this study, each period requires a 4 night stay. A follow-up visit is also required at approximately 7 days after the last dose administration. Starting from the first period to the follow-up, it will take about 1 month. Screening visit is required to be completed within 30 days prior to the first dose.

MAALOX® is a registered trademark of Novartic Consumer Health, LLC. ONE A DAY® is a registered trademark of Bayer Healthcare LLC.

Conditions: Healthy Volunteer
Being tested: GSK1349572 and MaaloxAdvanced Maximum Strength, GSK1349572 and Maalox Advanced Maximum Strength, GSK1349572 and One A Day, GSK1349572
Keywords: Healthy Volunteers, Drug interation, Pharmacokinetics

What participants receive

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

GSK1349572 and MaaloxAdvanced Maximum StrengthDrug
A single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength
GSK1349572 and Maalox Advanced Maximum StrengthDrug
A single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength
GSK1349572 and One A DayDrug
A single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin
GSK1349572Drug
A single dose of GSK1349572

Study groups in NCT00858455
Study group	Role	What they receive
Healthy Volunteers	Experimental	4 period cross over Receives: Drug: GSK1349572 and MaaloxAdvanced Maximum Strength; Drug: GSK1349572 and Maalox Advanced Maximum Strength; Drug: GSK1349572 and One A Day; Drug: GSK1349572

What is being measured

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

Single dose plasma GSK1349572 PK parameters including AUC(0-∞), Cmax, and C24 will be obtained to compare single dose plasma GSK1349572 PK with that of GSK1349572 after dministration with Maalox and One A Day as per the study design in the protocol
Measured: PK samples will be commected and analyzed starting with pre-dose and going for up to 72 hours post dose in each period in each study period

Secondary outcomes (1)

Safety and tolerability parameters, including adverse event, concurrent medication,clinical laboratory, ECG, and vital signs assessments. Single dose plasma GSK1349572 PK parameters: AUC(0-t), AUC(0-24), tlag, tmax, CL/F, and t1/2.
Measured: Data will be collected from Dosing until the final follow-up after completion of all study periods.

Timeline

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

Jan 2009Mar 2009

First posted9 Mar 2009 (estimated)
Study startJan 2009
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00858455
Sponsor's protocol ID: 111602
Other IDs: ING111602
Acronym: DDI
Status last verified: May 2009
First submitted: 22 Jan 2009
Last updated: 5 Jun 2009
Results posted: 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 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Maalox® Advanced Maximum Strength and One A Day® Maximum on Pharmacokinetics of GSK1349572 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT00858455
Acronym / sponsor ID: DDI / 111602
Conditions: Healthy Volunteer
Keywords: Healthy Volunteers, Drug interation, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Shionogi
Study start: Jan 2009
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 9 Mar 2009 (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.

MAALOX® is a registered trademark of Novartic Consumer Health, LLC. ONE A DAY® is a registered trademark of Bayer Healthcare LLC.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy Volunteers	Experimental	Drug: GSK1349572 and MaaloxAdvanced Maximum Strength, Drug: GSK1349572 and Maalox Advanced Maximum Strength, Drug: GSK1349572 and One A Day, Drug: GSK13495724 period cross over

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Male or female between 18 and 65 years of age.
A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or

Key exclusion criteria (18 listed)

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
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).
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.
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.

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
GSK1349572 and MaaloxAdvanced Maximum StrengthA single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength	Drug	Healthy Volunteers
GSK1349572 and Maalox Advanced Maximum StrengthA single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength	Drug	Healthy Volunteers
GSK1349572 and One A DayA single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin	Drug	Healthy Volunteers
GSK1349572A single dose of GSK1349572	Drug	Healthy Volunteers

Primary outcome

Single dose plasma GSK1349572 PK parameters including AUC(0-∞), Cmax, and C24 will be obtained to compare single dose plasma GSK1349572 PK with that of GSK1349572 after dministration with Maalox and One A Day as per the study design in the protocol
Time frame: PK samples will be commected and analyzed starting with pre-dose and going for up to 72 hours post dose in each period in each study period

1 secondary outcome

Safety and tolerability parameters, including adverse event, concurrent medication,clinical laboratory, ECG, and vital signs assessments. Single dose plasma GSK1349572 PK parameters: AUC(0-t), AUC(0-24), tlag, tmax, CL/F, and t1/2.
Time frame: Data will be collected from Dosing until the final follow-up after completion of all study periods.

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 5 Jun 2009.

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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 10 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 5 Jun 2009. 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?

Single dose plasma GSK1349572 PK parameters including AUC(0-∞), Cmax, and C24 will be obtained to compare single dose plasma GSK1349572 PK with that of GSK1349572 after dministration with Maalox and One A Day as per the study design in the protocol (time frame: PK samples will be commected and analyzed starting with pre-dose and going for up to 72 hours post dose in each period in each study period). 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 NCT00858455.

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 5 Jun 2009.