Healthy SubjectsPhase 1NCT00631592
GSK1349572 Repeat Dose Escalation and Relative Bioavailability Study
A Phase 1 study testing GSK1349572 in people with Healthy Subjects, run by ViiV Healthcare at 1 site in United States.
Trial summary
This is a repeat dose escalation study of GSK1349572 followed by a relative bioavailability study comparing tablet and suspension formulations in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- GSK1349572
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2008
- 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 physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 50 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 post-menopausal 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.
- Male subjects must agree to use one of the contraception methods listed in protocol. 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 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
- 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.
- 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 regular alcohol consumption within 6 months of the study defined as:
- 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.
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- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- 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.
- 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.
- screening ECG within protocol parameters (a single repeat is allowed for eligibility determination):• Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
- Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], WPW syndrome).
- Sinus Pauses > 3 seconds.
- Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
- Non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats).
- 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.
- History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- History/evidence of clinically significant pulmonary disease.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct bilirubin or creatinine values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.
- History of significant renal or hepatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GSK1349572 Repeat Dose Escalation Study
This is a repeat dose escalation study of GSK1349572 followed by a relative bioavailability study comparing tablet and suspension formulations in healthy volunteers.
Read the detailed description
ING111322: A Double-Blind, Randomized, Placebo-Controlled, Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1349572 Followed by A Single Dose, Randomized, 3-Period, Balanced, Crossover Study to Assess the Relative Bioavailability of Two Formulations and Food Effect on GSK1349572 in Healthy Male and Female Subjects
- Conditions
- Healthy Subjects
- Being tested
- GSK1349572
- Keywords
- GSK1349572,, healthy volunteers,, repeat dose,, relative bioavailability, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1349572Drug
| Study group | Role | What they receive |
|---|---|---|
| GSK1349572 | Other | GSK1349572 Receives: Drug: GSK1349572 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events; clinical hematology, clinical chemistry, urinalysis, vital signs (blood pressure and heart rate), electrocardiogram (ECG) intervals, ECG rhythm, and ECG axis from predose values, pharmacokinetic parameters throughout the study
Measured: throughout the study
Secondary outcomes (5)
Pre-morning dose concentrations (Ct) on Day 2 through 10 to assess the achievement of steady state of GSK1349572 following repeat administration.
Measured: day 2 thru day10
Day 10 AUC(0-t), Cmax, C0, Ct, and Cmin following last repeat dose administration at different doses for the assessment of dose proportionality.
Measured: day 10
Single dose plasma GSK1349572 pharmacokinetic parameters: tmax, t1/2, tlag and CL/F.
Measured: single dose
pharmacokinetic parameters
Measured: throughout the study
Plasma AUC(0-t) and AUC(0-¥) of midazolam, with and without GSK1349572 co-administration (Day -1 and Day 10).
Measured: Day -1 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631592
- Sponsor's protocol ID
- ING111322
- Status last verified
- Oct 2010
- First submitted
- 27 Feb 2008
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GSK1349572 Repeat Dose Escalation Study
- ClinicalTrials.gov ID
- NCT00631592
- Acronym / sponsor ID
- ING111322
- Conditions
- Healthy Subjects
- Keywords
- GSK1349572,, healthy volunteers,, repeat dose,, relative bioavailability, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Mar 2008 (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 repeat dose escalation study of GSK1349572 followed by a relative bioavailability study comparing tablet and suspension formulations in healthy volunteers.
Detailed description
ING111322: A Double-Blind, Randomized, Placebo-Controlled, Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1349572 Followed by A Single Dose, Randomized, 3-Period, Balanced, Crossover Study to Assess the Relative Bioavailability of Two Formulations and Food Effect on GSK1349572 in Healthy Male and Female Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1349572 | Other | Drug: GSK1349572GSK1349572 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 50 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:
- Male subjects must agree to use one of the contraception methods listed in protocol. 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 BMI within the range 18.5-31.0 kg/m2 (inclusive).
Key exclusion criteria (25 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.
- 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 regular alcohol consumption within 6 months of the study defined as:
- 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).
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 | Drug | GSK1349572 |
Primary outcome
adverse events; clinical hematology, clinical chemistry, urinalysis, vital signs (blood pressure and heart rate), electrocardiogram (ECG) intervals, ECG rhythm, and ECG axis from predose values, pharmacokinetic parameters throughout the study
Time frame: throughout the study
5 secondary outcomes
Pre-morning dose concentrations (Ct) on Day 2 through 10 to assess the achievement of steady state of GSK1349572 following repeat administration.
Time frame: day 2 thru day10
Day 10 AUC(0-t), Cmax, C0, Ct, and Cmin following last repeat dose administration at different doses for the assessment of dose proportionality.
Time frame: day 10
Single dose plasma GSK1349572 pharmacokinetic parameters: tmax, t1/2, tlag and CL/F.
Time frame: single dose
pharmacokinetic parameters
Time frame: throughout the study
Plasma AUC(0-t) and AUC(0-¥) of midazolam, with and without GSK1349572 co-administration (Day -1 and Day 10).
Time frame: Day -1 and Day 10
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 3 Feb 2017.
- Individual participant dataSharing planned: No
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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, MD 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 in people with Healthy Subjects, 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 8 inclusion and 25 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events; clinical hematology, clinical chemistry, urinalysis, vital signs (blood pressure and heart rate), electrocardiogram (ECG) intervals, ECG rhythm, and ECG axis from predose values, pharmacokinetic parameters throughout the study (time frame: throughout the study). 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 3 Feb 2017.