Healthy VolunteerPhase 1NCT00883935

GSK1349572 Drug Interaction Study With Atazanavir/Ritonavir and Atazanavir

A Phase 1 study testing GSK1349572, Atazanavir 300 mg and Atazanavir 400 mg 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

The purpose of this study is to compare the amount of GSK1349572 (study drug) in the blood when given with and without atazanavir/ritonavir or atazanavir and to compare the blood levels of atazanavir when given with GSK1349572 to historical data for atazanavir. Read more about this study

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, Atazanavir 300 mg and Atazanavir 400 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Jun 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

AST, ALT, and alkaline phosphatase less than or equal to 1.5xULN. Total bilirubin must be less than ULN.
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 65 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, hysterectomy or bilateral oophorectomy; 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].
Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 14 days post-last dose.
Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.0-32.0 kg/m2 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

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, including sulfa-containing drugs, 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.
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.

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Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
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, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease.
History/evidence of clinically significant pulmonary disease.
History of significant renal or hepatobiliary diseases. Subjects with a history of nephrolithiasis will be excluded.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
A positive test for HIV antibody.
History of 2nd degree or higher AV block.
History of Gilbert's disease.
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.
Dcreening ECG within protocol limits (a single repeat is allowed for eligibility determination)

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Austin, Texas, 78744

Other trials in United States

About this study

Official title: Phase I, Open Label, Randomized, Drug-Drug Interaction Study in Healthy Subjects to Investigate the Effects of Co-Administered Atazanavir/Ritonavir (300mg/100mg) or Atazanavir 400mg Administered Once Daily on the Steady-State Plasma Pharmacokinetics of GSK1349572 30mg Administered Once Daily

Read the detailed description

GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. As GSK1349572 progresses into clinical trials in HIV-infected patients where combination antiretroviral therapy is the standard of care, it is likely that it will be dosed with protease inhibitors (PIs) including atazanavir/ritonavir (ATV/RTV) and atazanavir alone. Ritonavir is a substrate of CYP3A and inhibitor of CYP3A and Pgp and atazanavir is an inhibitor of UGT1A1. Ritonavir is also a known inducer of CYP and UGT enzymes. As GSK1349572 likely undergoes metabolism by CYP and UGT enzymes and is a Pgp substrate, a drug interaction study between GSK1349572 and ATV is warranted. GSK1349572 is not an inhibitor or inducer of CYP3A and is not expected to have impact on pharmacokinetics (PK) of atazanavir and ritonavir. Accordingly, the primary objective of this study is to compare steady-state plasma PK, safety and tolerability of GSK1349572 30 mg every 24h (q24h) with and without ATV/RTV 300/100 mg q24h or ATV 400mg q24h.

Approximately 24 subjects will receive GSK1349572 30mg q24h for 5 days (Treatment A). Subjects will then be administered GSK1349572 30mg q24h in combination with either ATV/RTV 300/100 mg q24h (Treatment B, n=12) or ATV 400 mg q24h (Treatment C, n=12) for 14 days. There will be no washout between treatments. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug.

This study will be conducted at one center in the US, with healthy adult male and female subjects.

Conditions: Healthy Volunteer
Being tested: GSK1349572, Atazanavir 300 mg, Atazanavir 400 mg, Ritonavir
Keywords: GSK1349572, Atazanavir, Ritonavir, Reyataz, Norvir, healthy, pharmacokinetic

What participants receive

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

GSK1349572Drug
GSK1349572 30 mg once a day for 5 days in Period 1 and 14 days in Period 2
Atazanavir 300 mgDrug
Also called ATV, REYATAZ. REYATAZ is a registered trademark of Bristol-Myers Squibb Company
Atazanavir 300 mg once per day for 14 days in Period 2
Atazanavir 400 mgDrug
Also called REYATAZ. REYATAZ is a registered trademark of Bristol-Myers Squibb Company, ATV
Atazanavir 400 mg once a day for 14 days in Period 2
RitonavirDrug
Also called NORVIR. NORVIR is a registered trademark of Abbott Labs, RTV
Ritonavir 100 mg once a day for 14 days in Period 2

Study groups in NCT00883935
Study group	Role	What they receive
Sequence 2	Experimental	In the first treatment period, all subjects will receive GSK1349572 30mg q24h for 5 days (treatment A). In period two, subjects will receive GSK1349572 30mg q24h in combination with ATV 400mg q24h (treatment C) for 14 days. There will be no washout between treatment periods. Day 1 of Period 2 will be the day after Day 5 of Period 1. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. Receives: Drug: GSK1349572; Drug: Atazanavir 400 mg
Sequence 1	Experimental	In the first treatment period, all subjects will receive GSK1349572 30mg q24h for 5 days (treatment A). In period two, subjects will receive GSK1349572 30mg q24h in combination with ATV/RTV 300/100mg q24h (treatment B) for 14 days. There will be no washout between treatment periods. Day 1 of Period 2 will be the day after Day 5 of Period 1. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. Receives: Drug: GSK1349572; Drug: Atazanavir 300 mg; Drug: Ritonavir

What is being measured

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

Plasma GSK1349572 steady-state AUC(0-tau), Cmax, C0, Ctau, and Cmin following administration of GSK1349572 30mg q24h for 5 days and following co-administration with ATV/RTV 300/100mg q24h or ATV 400mg q24h for 14 days.
Measured: 19 days

Secondary outcomes (3)

Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments.
Measured: 19 days
Plasma GSK1349572 PK parameters: tmax, tmin, CL/F and t½, following administration of GSK1349572 30mg q24h for 5 days and following co-administration with ATZ/RTV 300/100mg q24h or ATZ 400mg q24h for 14 days.
Measured: 19 days
Plasma ATV PK parameters, including AUC(0-tau), Cmax, Ctau, and Cmin following co-administration of GSK1349572 30mg q24h and ATV/RTV 300/100mg q24h or ATV 400mg q24h for 14 days.
Measured: 19 days

Timeline

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

Apr 2009Jun 2009

First posted20 Apr 2009 (estimated)
Study startApr 2009
Primary completionJun 2009
Study completionJun 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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00883935
Sponsor's protocol ID: 111854
Status last verified: Jun 2009
First submitted: 16 Apr 2009
Last updated: 22 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open Label, Randomized, Drug-Drug Interaction Study in Healthy Subjects to Investigate the Effects of Co-Administered Atazanavir/Ritonavir (300mg/100mg) or Atazanavir 400mg Administered Once Daily on the Steady-State Plasma Pharmacokinetics of GSK1349572 30mg Administered Once Daily
ClinicalTrials.gov ID: NCT00883935
Acronym / sponsor ID: 111854
Conditions: Healthy Volunteer
Keywords: GSK1349572, Atazanavir, Ritonavir, Reyataz, Norvir, healthy, pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Shionogi
Study start: Apr 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 20 Apr 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.

Detailed description

This study will be conducted at one center in the US, with healthy adult male and female subjects.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 2	Experimental	Drug: GSK1349572, Drug: Atazanavir 400 mgIn the first treatment period, all subjects will receive GSK1349572 30mg q24h for 5 days (treatment A). In period two, subjects will receive GSK1349572 30mg q24h in combination with ATV 400mg q24h (treatment C) for 14 days. There will be no washout between treatment periods. Day 1 of Period 2 will be the day after Day 5 of Period 1. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.
Sequence 1	Experimental	Drug: GSK1349572, Drug: Atazanavir 300 mg, Drug: RitonavirIn the first treatment period, all subjects will receive GSK1349572 30mg q24h for 5 days (treatment A). In period two, subjects will receive GSK1349572 30mg q24h in combination with ATV/RTV 300/100mg q24h (treatment B) for 14 days. There will be no washout between treatment periods. Day 1 of Period 2 will be the day after Day 5 of Period 1. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.

Who may qualify

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

Key inclusion criteria (7 listed)

AST, ALT, and alkaline phosphatase less than or equal to 1.5xULN. Total bilirubin must be less than ULN.
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 65 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, hysterectomy or bilateral oophorectomy; 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].
Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 14 days post-last dose.

Key exclusion criteria (22 listed)

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, including sulfa-containing drugs, 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.

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
GSK1349572GSK1349572 30 mg once a day for 5 days in Period 1 and 14 days in Period 2	Drug	Sequence 1, Sequence 2
Atazanavir 300 mgAlso: ATV, REYATAZ. REYATAZ is a registered trademark of Bristol-Myers Squibb CompanyAtazanavir 300 mg once per day for 14 days in Period 2	Drug	Sequence 1
Atazanavir 400 mgAlso: REYATAZ. REYATAZ is a registered trademark of Bristol-Myers Squibb Company, ATVAtazanavir 400 mg once a day for 14 days in Period 2	Drug	Sequence 2
RitonavirAlso: NORVIR. NORVIR is a registered trademark of Abbott Labs, RTVRitonavir 100 mg once a day for 14 days in Period 2	Drug	Sequence 1

Primary outcome

Plasma GSK1349572 steady-state AUC(0-tau), Cmax, C0, Ctau, and Cmin following administration of GSK1349572 30mg q24h for 5 days and following co-administration with ATV/RTV 300/100mg q24h or ATV 400mg q24h for 14 days.
Time frame: 19 days

3 secondary outcomes

Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments.
Time frame: 19 days
Plasma GSK1349572 PK parameters: tmax, tmin, CL/F and t½, following administration of GSK1349572 30mg q24h for 5 days and following co-administration with ATZ/RTV 300/100mg q24h or ATZ 400mg q24h for 14 days.
Time frame: 19 days
Plasma ATV PK parameters, including AUC(0-tau), Cmax, Ctau, and Cmin following co-administration of GSK1349572 30mg q24h and ATV/RTV 300/100mg q24h or ATV 400mg q24h for 14 days.
Time frame: 19 days

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 22 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?

A Phase 1 study testing GSK1349572, Atazanavir 300 mg and Atazanavir 400 mg in people with Healthy Volunteer, 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 7 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 22 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?

Plasma GSK1349572 steady-state AUC(0-tau), Cmax, C0, Ctau, and Cmin following administration of GSK1349572 30mg q24h for 5 days and following co-administration with ATV/RTV 300/100mg q24h or ATV 400mg q24h for 14 days. (time frame: 19 days). 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 NCT00883935.

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 22 Jun 2009.