Infection, Human Immunodeficiency VirusPhase 1NCT01031472
A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761
A Phase 1 study testing GSK2248761 formulation 1, GSK2248761 reference formulation and GSK2248761 formulation 3 in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- GSK2248761 formulation 1, GSK2248761 reference formulation and GSK2248761 formulation 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2009to 11 Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 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 ECGs.
- Male or female between 18 and 50 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 Section 8.1. This criterion must be followed from the time of the first dose of study medication until the follow-up visit.
- 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 18.5-31.0 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.
- 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).
- The subject has received GSK2248761 in a previous clinical trial.
- 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 >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
- Lactating females.
- The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects at Screening and predose Day 1.
- Cardiac conduction abnormalities on a single 12-lead ECG at screening or predose Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Two Part, Open-label, Crossover Study to Assess the Relative Bioavailability and Food Effect of New Formulations of GSK2248761 in Healthy Adult Subjects
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.
- Being tested
- GSK2248761 formulation 1, GSK2248761 reference formulation, GSK2248761 formulation 3, GSK2248761 formulation 2 or 4
- Keywords
- HIV, relative bioavailability, food effect, GSK2248761, healthy subjects, HIV Seronegativity
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2248761 formulation 1Drug
100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal)
GSK2248761 reference formulationDrug
GSK2248761 100mg Gelucire reference capsule with food
GSK2248761 formulation 3Drug
100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal)
GSK2248761 formulation 2 or 4Drug
100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal)
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Subjects will be randomized in a three way crossover design to either a single dose of GSK2248761 100mg Gelucire capsule administered with food and a single dose of 100mg of formulation 1 or a single dose of 100mg of formulation 3 administered in the fed and fasted state Receives: Drug: GSK2248761 formulation 1; Drug: GSK2248761 reference formulation; Drug: GSK2248761 formulation 3 |
| Part B | Experimental | A total of twelve subjects who complete Part A will participate in Part B. Subjects from Part A will be asked to participate on a first come first serve basis until there are 12 subjects, at which time enrolment to Part B will be closed. Part B will be a 2 way cross over study design. Subjects will be randomized to one of a single dose of GSK2248761 100mg Formulation 2 or 4 (based on the evaluation of Part A data) administered with food or in the fasted state. Subjects in Part B will not receive the reference formulation since they previously received this in Part A Receives: Drug: GSK2248761 formulation 2 or 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve zero to infinity of plasma GSK2248761
Plasma samples will be collected for the analysis of AUC (0-inf) of GSK2248761.
Measured: Up to 5 weeks
AUC from time zero to end of dosing interval AUC (0-tau)
Plasma samples will be collected for the analysis AUC (0-tau) of GSK2248761.
Measured: Up to 5 weeks
Maximum concentration (Cmax) of GSK2248761
Plasma samples will be collected for the analysis of Cmax of GSK2248761.
Measured: Up to 5 weeks
Secondary outcomes (10)
Terminal half life (t1/2) of GSK2248761
Plasma samples will be collected for the analysis of t1/2 of GSK2248761.
Measured: Up to 5 weeks
Lag time before observation of drug concentration (tlag) of GSK2248761
Plasma samples will be collected for the analysis of tlag of GSK2248761.
Measured: Up to 5 weeks
Time to Cmax of GSK2248761
Plasma samples will be collected for the analysis of Tmax of GSK2248761.
Measured: Up to 5 weeks
Percentage of AUC obtained by extrapolation (%AUCex) for GSK2248761
Plasma samples will be collected for the analysis of %AUCex for GSK2248761.
Measured: Up to 5 weeks
Apparent clearance following oral dosing (CL/F) for GSK2248761
Plasma samples will be collected for the analysis of CL/F for GSK2248761.
Measured: Up to 5 weeks
Number of participants with seious adverse events (SAEs) and non-serious adverse events (non-SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Measured: Up to 5 weeks
Number of participants with concurrent medication
Number of participants with concurrent medication will be summarized.
Measured: Up to 5 weeks
Number of participants with abnormal clinical laboratory parameters
Blood samples will be collected for the analysis of clinical laboratory parameters.
Measured: Up to 5 weeks
Number of participants with abnormal electrocardiogram (ECG) values
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
Measured: Up to 5 weeks
Number of participants with abnormal vital signs
Vital signs will be measured at indicated time points in semi-supine position after 5 minutes rest.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start21 Dec 2009
- Primary completion11 Mar 2010
- Study completion11 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01031472
- Sponsor's protocol ID
- 113391
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2009
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Two Part, Open-label, Crossover Study to Assess the Relative Bioavailability and Food Effect of New Formulations of GSK2248761 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01031472
- Acronym / sponsor ID
- 113391
- Keywords
- HIV, relative bioavailability, food effect, GSK2248761, healthy subjects, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 21 Dec 2009 (actual)
- Primary completion
- 11 Mar 2010 (actual)
- Study completion
- 11 Mar 2010 (actual)
- First posted
- 14 Dec 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.
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: GSK2248761 formulation 1, Drug: GSK2248761 reference formulation, Drug: GSK2248761 formulation 3Subjects will be randomized in a three way crossover design to either a single dose of GSK2248761 100mg Gelucire capsule administered with food and a single dose of 100mg of formulation 1 or a single dose of 100mg of formulation 3 administered in the fed and fasted state |
| Part B | Experimental | Drug: GSK2248761 formulation 2 or 4A total of twelve subjects who complete Part A will participate in Part B. Subjects from Part A will be asked to participate on a first come first serve basis until there are 12 subjects, at which time enrolment to Part B will be closed. Part B will be a 2 way cross over study design. Subjects will be randomized to one of a single dose of GSK2248761 100mg Formulation 2 or 4 (based on the evaluation of Part A data) administered with food or in the fasted state. Subjects in Part B will not receive the reference formulation since they previously received this in Part A |
Who may qualify
- Ages
- 18 to 50 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 ECGs.
- Male or female between 18 and 50 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 Section 8.1. This criterion must be followed from the time of the first dose of study medication until the follow-up visit.
Key exclusion criteria (22 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 |
|---|---|---|
| GSK2248761 formulation 1100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal) | Drug | Part A |
| GSK2248761 reference formulationGSK2248761 100mg Gelucire reference capsule with food | Drug | Part A |
| GSK2248761 formulation 3100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal) | Drug | Part A |
| GSK2248761 formulation 2 or 4100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal) | Drug | Part B |
Primary outcome
Area under the concentration-time curve zero to infinity of plasma GSK2248761
Time frame: Up to 5 weeks
Plasma samples will be collected for the analysis of AUC (0-inf) of GSK2248761.
AUC from time zero to end of dosing interval AUC (0-tau)
Time frame: Up to 5 weeks
Plasma samples will be collected for the analysis AUC (0-tau) of GSK2248761.
Maximum concentration (Cmax) of GSK2248761
Time frame: Up to 5 weeks
Plasma samples will be collected for the analysis of Cmax of GSK2248761.
10 secondary outcomes
Terminal half life (t1/2) of GSK2248761
Time frame: Up to 5 weeks
Lag time before observation of drug concentration (tlag) of GSK2248761
Time frame: Up to 5 weeks
Time to Cmax of GSK2248761
Time frame: Up to 5 weeks
Percentage of AUC obtained by extrapolation (%AUCex) for GSK2248761
Time frame: Up to 5 weeks
Apparent clearance following oral dosing (CL/F) for GSK2248761
Time frame: Up to 5 weeks
Number of participants with seious adverse events (SAEs) and non-serious adverse events (non-SAEs)
Time frame: Up to 5 weeks
Number of participants with concurrent medication
Time frame: Up to 5 weeks
Number of participants with abnormal clinical laboratory parameters
Time frame: Up to 5 weeks
Number of participants with abnormal electrocardiogram (ECG) values
Time frame: Up to 5 weeks
Number of participants with abnormal vital signs
Time frame: Up to 5 weeks
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 27 Mar 2020.
- Results for study 113391 can be found on the ViiV Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
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 GSK2248761 formulation 1, GSK2248761 reference formulation and GSK2248761 formulation 3 in people with Infection, Human Immunodeficiency Virus and HIV Infections, 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 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 27 Mar 2020. 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?
Area under the concentration-time curve zero to infinity of plasma GSK2248761 (time frame: Up to 5 weeks). 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?
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 27 Mar 2020.