Infection, Human Immunodeficiency Virus IPhase 1NCT01283100
A Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1349572 Pharmacokinetics in Healthy Adult Subjects.
A Phase 1 study testing GSK1349572 and GSK2248761 in people with Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare at 1 site in United States.
Trial summary
This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data from 12 evaluable subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus I
- What is being tested?
- GSK1349572 and GSK2248761
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2011
- 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
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and electrocardiograms (ECGs).
- 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 (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 post-menopausal status. For this study, FSH levels > 40 MlU/ml 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 the follow-up visit.
- Body weight less than or equal to 50 kg for men and less than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 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
- As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
- 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.
- Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- History of regular alcohol consumption within 6 months of the study.
- Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
- History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
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- 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/evidence of pancreatitis.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- 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.
- 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).
- 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 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. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Note: this does not include plasma donation.
- 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.
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5x upper limit of normal (ULN) is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Pregnant females as determined by positive serum pregnancy test at screening or prior to dosing.
- Lactating females.
- The subject's systolic blood pressure is outside the range of 90-140 miligrams of mercury (mmHg), or diastolic blood pressure is outside the range of 45-90 mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female subjects or 45-100 bpm for male subjects at Screening and predose Day 1.
- Cardiac conduction abnormalities denoted by any of the following on a single 12-lead ECG at screening or predose Day 1 (a single repeat is allowed for eligibility determination).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Single Sequence, Two-Way Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1379572 Pharmacokinetics in Healthy Adult Subjects
This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data from 12 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will be the day after Day 5 of Period 2.
Read the detailed description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
- Being tested
- GSK1349572, GSK2248761
- Keywords
- HIV, GSK2248761, GSK1349572, drug interaction, pharmacokinetics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1349572Drug
50mg once every 24 hours for 7 days
GSK2248761Drug
200 mg once every 24 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | GSK1349572 50mg q24h x 7 days Receives: Drug: GSK1349572 |
| Treatment B | Experimental | GSK2248761 200mg q24h x 7 days Receives: Drug: GSK2248761 |
| Treatment C | Experimental | GSK1349572 50mg q24h x 7 days + GSK2248761 200mg q24h x 7 days Receives: Drug: GSK1349572; Drug: GSK2248761 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma GSK1349572 steady state area under the curve (AUC) 0-tau following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Measured: 21 days
Plasma GSK1349572 steady state maximum observed concentration (Cmax) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Measured: 21 days
Plasma GSK1349572 steady state Pre-dose trough concentration at the end of the dosing interval (Ctau) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Measured: 21 days
Plasma GSK1349572 steady state predose concentration (C0) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Measured: 21 days
Plasma GSK1349572 steady state minimum concentration (Cmin) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Measured: 21 days
Plasma GSK2248761 steady state steady state AUC 0-tau following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Measured: 21 days
Plasma GSK2248761 steady state Cmax following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Measured: 21 days
Plasma GSK2248761 steady state Ctau following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Measured: 21 days
Plasma GSK2248761 steady state Cmin following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Measured: 21 days
Plasma GSK2248761 steady state C0 following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Measured: 21 days
Secondary outcomes (14)
Safety and tolerability parameters, including the number of subjects with adverse events
Measured: approximately 42 days
Safety and tolerability parameters, including the number of subjects receiving concurrent medications
Measured: approximately 42 days
Safety and tolerability parameters, including change from baseline for clinical laboratory safety assessments
Measured: approximately 42 days
Safety and tolerability parameters, including change from baseline for electrocardiogram (ECG) assessments
Measured: approximately 42 days
Safety and tolerability parameters, including change from baseline for vital sign (blood pressure and heart rate) assessments
Measured: approximately 42 days
GSK1349572 PK parameters including time of occurrence of maximum concentration (tmax) following administration of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Measured: approximately 28 days
GSK1349572 PK parameters including time of occurrence of minimum concentration (Tmin) following administration of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Measured: 21 days
GSK1349572 PK parameters including apparent clearance following oral dosing (CL/F) of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Measured: 21 days
GSK1349572 PK parameters including terminal half life (t½) following administration of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Measured: 21 days
GSK2248761 PK parameters tmax following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3)
Measured: 21 days
GSK2248761 PK parameters tmin following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3).
Measured: 21 days
GSK2248761 PK parameters CL/F following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3).
Measured: 21 days
GSK2248761 PK parameters t½ following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3).
Measured: 21 days
GSK1349572 and GSK2248761 Ctau values on Days 4-7 for each Period
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2011
- Study completionJun 2011 (estimated)
Why it stopped: In a Phase II study in HIV-infected patients there were a number of seizures, although exact causality could not be assessed phase 1 activity was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency Virus IStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283100
- Sponsor's protocol ID
- 114122
- Status last verified
- Dec 2014
- First submitted
- 6 Jan 2011
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single Sequence, Two-Way Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1379572 Pharmacokinetics in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01283100
- Acronym / sponsor ID
- 114122
- Keywords
- HIV, GSK2248761, GSK1349572, drug interaction, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In a Phase II study in HIV-infected patients there were a number of seizures, although exact causality could not be assessed phase 1 activity was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data from 12 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will be the day after Day 5 of Period 2.
Detailed description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: GSK1349572GSK1349572 50mg q24h x 7 days |
| Treatment B | Experimental | Drug: GSK2248761GSK2248761 200mg q24h x 7 days |
| Treatment C | Experimental | Drug: GSK1349572, Drug: GSK2248761GSK1349572 50mg q24h x 7 days + GSK2248761 200mg q24h x 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and electrocardiograms (ECGs).
- 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 (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 post-menopausal status. For this study, FSH levels > 40 MlU/ml 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 the follow-up visit.
Key exclusion criteria (23 listed)
- As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
- 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.
- Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- History of regular alcohol consumption within 6 months of the study.
- Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
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 |
|---|---|---|
| GSK134957250mg once every 24 hours for 7 days | Drug | Treatment A, Treatment C |
| GSK2248761200 mg once every 24 hours for 7 days | Drug | Treatment B, Treatment C |
Primary outcome
Plasma GSK1349572 steady state area under the curve (AUC) 0-tau following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Time frame: 21 days
Plasma GSK1349572 steady state maximum observed concentration (Cmax) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Time frame: 21 days
Plasma GSK1349572 steady state Pre-dose trough concentration at the end of the dosing interval (Ctau) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Time frame: 21 days
Plasma GSK1349572 steady state predose concentration (C0) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Time frame: 21 days
Plasma GSK1349572 steady state minimum concentration (Cmin) following 50 mg q24h administration with and without GSK2248761 200 mg q24h
Time frame: 21 days
Plasma GSK2248761 steady state steady state AUC 0-tau following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Time frame: 21 days
Plasma GSK2248761 steady state Cmax following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Time frame: 21 days
Plasma GSK2248761 steady state Ctau following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Time frame: 21 days
Plasma GSK2248761 steady state Cmin following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Time frame: 21 days
Plasma GSK2248761 steady state C0 following 200 mg q24h administration with and without GSK1349572 50 mg q24h
Time frame: 21 days
14 secondary outcomes
Safety and tolerability parameters, including the number of subjects with adverse events
Time frame: approximately 42 days
Safety and tolerability parameters, including the number of subjects receiving concurrent medications
Time frame: approximately 42 days
Safety and tolerability parameters, including change from baseline for clinical laboratory safety assessments
Time frame: approximately 42 days
Safety and tolerability parameters, including change from baseline for electrocardiogram (ECG) assessments
Time frame: approximately 42 days
Safety and tolerability parameters, including change from baseline for vital sign (blood pressure and heart rate) assessments
Time frame: approximately 42 days
GSK1349572 PK parameters including time of occurrence of maximum concentration (tmax) following administration of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Time frame: approximately 28 days
GSK1349572 PK parameters including time of occurrence of minimum concentration (Tmin) following administration of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Time frame: 21 days
GSK1349572 PK parameters including apparent clearance following oral dosing (CL/F) of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Time frame: 21 days
GSK1349572 PK parameters including terminal half life (t½) following administration of GSK1349572 50 mg q24h with and without co-administration of GSK2248761 200 mg q24h (Day 7 in Period 1, Period 3)
Time frame: 21 days
GSK2248761 PK parameters tmax following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3)
Time frame: 21 days
GSK2248761 PK parameters tmin following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3).
Time frame: 21 days
GSK2248761 PK parameters CL/F following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3).
Time frame: 21 days
GSK2248761 PK parameters t½ following administration of GSK2248761 200 mg q24h with and without co-administration of GSK1349572 50 mg q24h (Day 7 in Period 2 and Day 7 in Period 3).
Time frame: 21 days
GSK1349572 and GSK2248761 Ctau values on Days 4-7 for each Period
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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
ViiV Healthcare
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 and GSK2248761 in people with Infection, Human Immunodeficiency Virus I, run by ViiV Healthcare 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 23 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: withdrawn, as of the sponsor's last update on 24 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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 area under the curve (AUC) 0-tau following 50 mg q24h administration with and without GSK2248761 200 mg q24h (time frame: 21 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.