Infection, Human Immunodeficiency VirusPhase 1NCT00723775
GSK706769/KALETRA Drug-drug Interaction Study
A Phase 1 study testing GSK706769 & KALETRA in people with Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 1 site in United States.
Trial summary
To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h 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
- What is being tested?
- GSK706769 & KALETRA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2008to 8 Nov 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 females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy;
- 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. Following confirmation of their post-menopausal status, they can resume use of HRT.
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of medication.
- Body weight >= 50 kg (110 lbs.) for men and >=45 kg (99 lbs) 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
- 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 defined as:
- An average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
- Note: 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.
Show all 23Show fewer
- 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.
- 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 hepatic diseases.
- 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 GSK706769 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.
- Note: "Study" or "investigational" drugs include GSK706769 or Kaletra
- 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.
- 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.
- Exclusion Criteria for 24-Hour Screening Holter per protocol (conducted only if telemetry is warranted from findings on telemetry from an ongoing repeat dose study):
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open Label Drug-drug Interaction Study in Healthy Volunteers to Evaluate the Effect of KALETRA (Lopinavir-ritonavir) on GSK706769 Pharmacokinetics and to Evaluate the Pharmacokinetics of a New Oral Formulation of GSK706769
To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- GSK706769 & KALETRA
- Keywords
- KALETRA, GSK706769, HIV, healthy volunteers
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK706769 & KALETRADrug
GSK706769 alone and GSK706769 + Kaletra
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Other | GSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra Receives: Drug: GSK706769 & KALETRA |
| Part 2 | Other | GSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days Receives: Drug: GSK706769 & KALETRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSK706769 PK
Measured: Part 1: 4 days; Part 2; 25 days
Secondary outcomes (5)
GSK706769 safety parameters, including adverse events, clinical laboratory, ECG, and vital signs assessments.
Measured: Part 1: 4 days; Part 2; 25 days
Plasma GSK706769 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Measured: Part 1: 4 days; Part 2; 25 days
Plasma metabolite GSK1996847 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Measured: Part 1: 4 days; Part 2; 25 days
Metabolite GSK1996847 AUC(0-t) and Cmax following repeat dose administration of GSK706769 QD for 10 days and following coadministration with Kaletra (LPV 400mg/RTV 100mg) q12h for 14 days.
Measured: Part 1: 4 days; Part 2; 25 days
Plasma protein and mRNA expression levels of biomarkers before and after administration of GSK706769 QD for 5 days.
Measured: Part 1: 4 days; Part 2; 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study start24 Jul 2008
- Primary completion8 Nov 2008
- Study completion8 Nov 2008
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723775
- Sponsor's protocol ID
- CRR110744
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2008
- Last updated
- 21 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label Drug-drug Interaction Study in Healthy Volunteers to Evaluate the Effect of KALETRA (Lopinavir-ritonavir) on GSK706769 Pharmacokinetics and to Evaluate the Pharmacokinetics of a New Oral Formulation of GSK706769
- ClinicalTrials.gov ID
- NCT00723775
- Acronym / sponsor ID
- CRR110744
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- KALETRA, GSK706769, HIV, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2008 (actual)
- Primary completion
- 8 Nov 2008 (actual)
- Study completion
- 8 Nov 2008 (actual)
- First posted
- 29 Jul 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.
To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Other | Drug: GSK706769 & KALETRAGSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra |
| Part 2 | Other | Drug: GSK706769 & KALETRAGSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days |
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:
- Is pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy;
- 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. Following confirmation of their post-menopausal status, they can resume use of HRT.
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 defined as:
- An average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
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 |
|---|---|---|
| GSK706769 & KALETRAGSK706769 alone and GSK706769 + Kaletra | Drug | Part 1, Part 2 |
Primary outcome
GSK706769 PK
Time frame: Part 1: 4 days; Part 2; 25 days
5 secondary outcomes
GSK706769 safety parameters, including adverse events, clinical laboratory, ECG, and vital signs assessments.
Time frame: Part 1: 4 days; Part 2; 25 days
Plasma GSK706769 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Time frame: Part 1: 4 days; Part 2; 25 days
Plasma metabolite GSK1996847 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Time frame: Part 1: 4 days; Part 2; 25 days
Metabolite GSK1996847 AUC(0-t) and Cmax following repeat dose administration of GSK706769 QD for 10 days and following coadministration with Kaletra (LPV 400mg/RTV 100mg) q12h for 14 days.
Time frame: Part 1: 4 days; Part 2; 25 days
Plasma protein and mRNA expression levels of biomarkers before and after administration of GSK706769 QD for 5 days.
Time frame: Part 1: 4 days; Part 2; 25 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 21 Jul 2017.
- Results for study CRR110744 can be found on the GSK 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
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 GSK706769 & KALETRA in people with Infection, Human Immunodeficiency Virus, 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 8 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: finished, as of the sponsor's last update on 21 Jul 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?
GSK706769 PK (time frame: Part 1: 4 days; Part 2; 25 days). 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 21 Jul 2017.