Atrophy, GeographicPhase 1NCT02033668
Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers
A Phase 1 study testing GSK933776 for SQ administration, GSK933776 for IM administration and GSK933776 for IV administration in people with Atrophy, Geographic, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous (SQ) administration for subsequent studies with GSK933776 by characterizing the safety, tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM and SQ administration 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
- Atrophy, Geographic
- What is being tested?
- GSK933776 for SQ administration, GSK933776 for IM administration and GSK933776 for IV administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2014to 15 Jul 2014
- 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
- Male or female subject 18 to 50 years of age at the time of signing the informed consent
- In general good health as determined by a 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 condition is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Body weight >=55 kilograms (kg) (121 pounds [lbs]) and <=85 kg (187 lbs) with a body mass index (BMI) between 18.5 and 29 kg per meter square (inclusively) 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 or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit (MIU)/milliliter (mL) and estradiol <40 picogram/mL (<140 picomoles/Liter) is confirmatory.
- Male subjects must agree to use one form of acceptable contraception methods if their partner is of childbearing potential. This criterion must be followed from the time of the screening visit through the follow up visit (84 days after last dose of study medication).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Known risk history of Central nervous system (CNS) disorders: History and/or evidence (computed tomography or magnetic resonance imaging scan performed within the past 12 months) of cerebral haemorrhage OR a known risk of cerebral haemorrhage, including uncontrolled hypertension, cerebrovascular malformation, coagulopathy, central nervous system (CNS) vasculitis, degenerative or inflammatory/demyelinating CNS conditions or any other condition that the Investigator and/or the medical monitor considers as a relevant risk factor for cerebral haemorrhage. Transient ischemic attack (TIA)/cerebrovascular accident (CVA) in the last year, or other uncontrolled risk factors for stroke; History of seizures (except febrile seizures in childhood) or recent unprovoked seizure; Uncontrolled type 2 diabetes mellitus (glycated hemoglobin >10%), active cardiovascular disease (e.g., moderate-severe angina, unstable angina, myocardial infarction (MI) within the last 2 years, symptomatic congestive heart failure, clinically significant arrhythmia); Current blood clotting or bleeding disorder or conditions that predispose to these (e.g. cancer); Diagnosis of currently active, or, in remission but chronic relapsing, systemic autoimmune disease or condition (e.g. multiple sclerosis, lupus erythematosus etc) that the Investigator and/or the medical monitor considers as a relevant risk factor for concomitant administration of a therapeutic monoclonal antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Use of prescription drugs or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days 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.
- A positive pre-study drug/alcohol screen. Current or recent drug or alcohol abuse or dependence. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 units for males or >7 units for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. Use of illegal drugs.
- 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.
- Seated systolic blood pressure >140 millimeter of mercury (mmHg) or seated diastolic blood pressure of > 90 mmHg
Show all 15Show fewer
- QTc >450 millisecond (msec).
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) >= 2xupper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Significant abnormalities on hematology screen: clinically significant anemia (i.e. hemoglobin <11 g/deciliter [dL] for males or <10 g/dL for females), or platelet counts below 124 Giga/L; International Normalized Ratio > 2.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for human immunodeficiency virus antibody
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Exposure to more than four new chemical entities within 12 months prior to screening.
- Prior allergic reactions to biological products (vaccines, antibodies) or known hypersensitivity to any of the components of the drug formulation.
- Prior participation in clinical investigations involving therapeutic monoclonal antibodies with a similar mode of action or proteins derived from monoclonal antibodies with any risk of cross- reactivity or any investigations of treatments or use of any other investigational medication or device within 2 months prior to screening or within 5 half-lives of use of such a medication prior to screening, whichever is longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Randomized, Open Label, Parallel-Group Study to Estimate Bioavailability and to Assess the Pharmacokinetic Profile, Safety and Tolerability of GSK933776 Administered by Subcutaneous or Intramuscular Injection Relative to Intravenous Administration to Healthy Volunteers
This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous (SQ) administration for subsequent studies with GSK933776 by characterizing the safety, tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM and SQ administration in healthy volunteers. Such alternate routes of administration may provide more options in the selection of an efficacious dose for subsequent development in patients with geographic atrophy. There will be four treatment arms in the study and participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The planned number of evaluable participants for this study is 24 with 6 participants completing all critical assessments in each of the four treatment arms. The total duration of participation from screening to follow-up for Treatment Arms A, B and D (single dose of GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat dose of GSK933776) will be approximately 134 days.
- Conditions
- Atrophy, Geographic
- Being tested
- GSK933776 for SQ administration, GSK933776 for IM administration, GSK933776 for IV administration
- Keywords
- bioavailability, Pharmacokinetics, intravenous, subcutaneous and intramuscular administration, amyloid beta, monoclonal antibody
- Medical subject headings
- Geographic Atrophy, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK933776 for SQ administrationDrug
Antibody solution for subcutaneous injection with unit dose strength of 50mg/mL administered as 200 mg single dose or as repeat dose of 50 mg weekly for 4 weeks
GSK933776 for IM administrationDrug
Antibody solution for intramuscular injection with unit dose strength of 50mg/mL administered as 200 mg single dose
GSK933776 for IV administrationDrug
Antibody solution for intravenous injection with unit dose strength of 50mg/mL administered as 200 mg single dose through an IV catheter over approximately 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Participants in this arm will receive single 200 milligram (mg) dose of GSK933776 administered by IV infusion Receives: Drug: GSK933776 for IV administration |
| Arm B | Experimental | Participants in this arm will receive single 200 mg dose of GSK933776 administered SQ Receives: Drug: GSK933776 for SQ administration |
| Arm C | Experimental | Participants in this arm will receive 50 mg dose of GSK933776 administered SQ once weekly for 4 weeks (total dose = 200 mg). Receives: Drug: GSK933776 for SQ administration |
| Arm D | Experimental | Participants in this arm will receive single 200 mg dose of GSK933776 administered IM Receives: Drug: GSK933776 for IM administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of GSK933776 after single dose SQ or IM administration as compared to IV infusion
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of area under concentration time curve from time zero to infinity (AUC [0-infinity]) following single dose SQ and IM injection to intravenous (IV) infusion
Measured: Blood samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose
Relative bioavailability of GSK933776 after repeat dose SQ administration as compared to IV infusion
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of AUC (0-infinity) following SQ repeat dose injections to intravenous (IV) infusion
Measured: Blood samples will be collected at following time points: pre-dose, 6, 24, 48, 72, 96 and 120 hours post dose in each of the 4 dosing weeks and additionally at 216, 336, 504, 672, 1344 and 2016 hours post last dose
Secondary outcomes (15)
Composite of PK parameters of GSK933776 following single dose IM and SQ administration as compared to IV administration
PK parameters include: area under the concentration-time curve over the dosing interval (AUC[0-tau]), maximum concentration (Cmax), time of occurrence of Cmax (Tmax), terminal phase half-life (T1/2), clearance, and volume of distribution as data permit
Measured: Samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose
Composite of PK parameters of GSK933776 following repeat dose SQ administration as compared to IV administration
PK parameters include: AUC(0-tau), Cmax, Tmax, T1/2, clearance, and volume of distribution as data permit
Measured: Blood samples will be collected at following time points: pre-dose, 6, 24, 48, 72, 96 and 120 hours post dose in each of the 4 dosing weeks and additionally at 216, 336, 504, 672, 1344 and 2016 hours post last dose.
Number of participants with adverse events as a measure of safety and tolerability following single dose administration
AEs will be collected from the start of Study Treatment and until the follow-up contact
Measured: Up to 113 days
Clinical observation following IV, SQ and IM single dose administration as a measure of safety and tolerability
AEs will be collected from the start of Study Treatment and until the follow-up contact
Measured: Up to 134 days
Clinical observation following IV, SQ and IM repeat dose administration as a measure of safety and tolerability
Clinical observation include: physical examination, medical history, and review of concomitant medication
Measured: Up to 113 days
Vital sign measurement following single dose administration as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, and body temperature measurement.
Measured: Up to 134 days
Vital sign measurement following repeat dose administration as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, and body temperature measurement.
Measured: Up to 134 days
Electrocardiogram (ECG) measurement following single dose administration to assess safety and tolerability
12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc interval).
Measured: Up to 113 days
ECG measurement following repeat dose administration to assess safety and tolerability
12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc interval.
Measured: Up to 134 days
Clinical laboratory parameters assessment following single dose administration as a measure of safety and tolerability
Clinical laboratory assessment include: hematology, clinical chemistry, urinalysis and additional parameters.
Measured: Up to 113 days
Clinical laboratory parameters assessment following repeat dose administration as a measure of safety and tolerability
Clinical laboratory assessment include: hematology, clinical chemistry, urinalysis and additional parameters.
Measured: Up to 134 days
Plasma concentrations of GSK933776, total amyloid beta (AB), total AB fragments, as well as unbound concentrations of AB, fragments containing the epitope 1-22, as data permit following single dose administrationof GSK933776
The relationship between plasma concentration of GSK933776 and plasma concentration of total and free amyloid beta will be explored as data permit
Measured: Up to 113 days
Plasma concentration of GSK933776, AB, total AB fragments, as well as unbound concentrations of AB, fragments containing the epitope 1-22, as data permit following repeat dose administration
The relationship between plasma concentration of GSK933776 and plasma concentration of total and free amyloid beta will be explored as data permit
Measured: Up to 134 days
Presence of antibodies to GSK933776 in serum samples following single dose administration of GSK933776
To characterize the immunogenicity profile of GSK933776 following IV, IM and SQ administration. Samples will be analyzed for the presence of anti-GSK933776 antibodies by immuno-electrochemiluminescent (ECL) screening and neutralization assays.
Measured: Up to 113 days
Presence of antibodies to GSK933776 in serum samples following repeat dose administration
To characterize the immunogenicity profile of GSK933776 following IV, IM and SQ administration. Samples will be analyzed for the presence of anti-GSK933776 antibodies by immuno-electrochemiluminescent (ECL) screening and neutralization assays.
Measured: Up to 134 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start22 Jan 2014
- Primary completion15 Jul 2014
- Study completion15 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy, GeographicStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033668
- Sponsor's protocol ID
- 116891
- Status last verified
- May 2017
- First submitted
- 9 Jan 2014
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Parallel-Group Study to Estimate Bioavailability and to Assess the Pharmacokinetic Profile, Safety and Tolerability of GSK933776 Administered by Subcutaneous or Intramuscular Injection Relative to Intravenous Administration to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02033668
- Acronym / sponsor ID
- 116891
- Conditions
- Atrophy, Geographic
- Keywords
- bioavailability, Pharmacokinetics, intravenous, subcutaneous and intramuscular administration, amyloid beta, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 22 Jan 2014 (actual)
- Primary completion
- 15 Jul 2014 (actual)
- Study completion
- 15 Jul 2014 (actual)
- First posted
- 13 Jan 2014 (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 study is intended to enable a possible transition to intramuscular (IM) or subcutaneous (SQ) administration for subsequent studies with GSK933776 by characterizing the safety, tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM and SQ administration in healthy volunteers. Such alternate routes of administration may provide more options in the selection of an efficacious dose for subsequent development in patients with geographic atrophy. There will be four treatment arms in the study and participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The planned number of evaluable participants for this study is 24 with 6 participants completing all critical assessments in each of the four treatment arms. The total duration of participation from screening to follow-up for Treatment Arms A, B and D (single dose of GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat dose of GSK933776) will be approximately 134 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: GSK933776 for IV administrationParticipants in this arm will receive single 200 milligram (mg) dose of GSK933776 administered by IV infusion |
| Arm B | Experimental | Drug: GSK933776 for SQ administrationParticipants in this arm will receive single 200 mg dose of GSK933776 administered SQ |
| Arm C | Experimental | Drug: GSK933776 for SQ administrationParticipants in this arm will receive 50 mg dose of GSK933776 administered SQ once weekly for 4 weeks (total dose = 200 mg). |
| Arm D | Experimental | Drug: GSK933776 for IM administrationParticipants in this arm will receive single 200 mg dose of GSK933776 administered IM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subject 18 to 50 years of age at the time of signing the informed consent
- In general good health as determined by a 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 condition is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Body weight >=55 kilograms (kg) (121 pounds [lbs]) and <=85 kg (187 lbs) with a body mass index (BMI) between 18.5 and 29 kg per meter square (inclusively) 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 or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit (MIU)/milliliter (mL) and estradiol <40 picogram/mL (<140 picomoles/Liter) is confirmatory.
- Male subjects must agree to use one form of acceptable contraception methods if their partner is of childbearing potential. This criterion must be followed from the time of the screening visit through the follow up visit (84 days after last dose of study medication).
Key exclusion criteria (15 listed)
- Known risk history of Central nervous system (CNS) disorders: History and/or evidence (computed tomography or magnetic resonance imaging scan performed within the past 12 months) of cerebral haemorrhage OR a known risk of cerebral haemorrhage, including uncontrolled hypertension, cerebrovascular malformation, coagulopathy, central nervous system (CNS) vasculitis, degenerative or inflammatory/demyelinating CNS conditions or any other condition that the Investigator and/or the medical monitor considers as a relevant risk factor for cerebral haemorrhage. Transient ischemic attack (TIA)/cerebrovascular accident (CVA) in the last year, or other uncontrolled risk factors for stroke; History of seizures (except febrile seizures in childhood) or recent unprovoked seizure; Uncontrolled type 2 diabetes mellitus (glycated hemoglobin >10%), active cardiovascular disease (e.g., moderate-severe angina, unstable angina, myocardial infarction (MI) within the last 2 years, symptomatic congestive heart failure, clinically significant arrhythmia); Current blood clotting or bleeding disorder or conditions that predispose to these (e.g. cancer); Diagnosis of currently active, or, in remission but chronic relapsing, systemic autoimmune disease or condition (e.g. multiple sclerosis, lupus erythematosus etc) that the Investigator and/or the medical monitor considers as a relevant risk factor for concomitant administration of a therapeutic monoclonal antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Use of prescription drugs or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days 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.
- A positive pre-study drug/alcohol screen. Current or recent drug or alcohol abuse or dependence. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 units for males or >7 units for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. Use of illegal drugs.
- 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.
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 |
|---|---|---|
| GSK933776 for SQ administrationAntibody solution for subcutaneous injection with unit dose strength of 50mg/mL administered as 200 mg single dose or as repeat dose of 50 mg weekly for 4 weeks | Drug | Arm B, Arm C |
| GSK933776 for IM administrationAntibody solution for intramuscular injection with unit dose strength of 50mg/mL administered as 200 mg single dose | Drug | Arm D |
| GSK933776 for IV administrationAntibody solution for intravenous injection with unit dose strength of 50mg/mL administered as 200 mg single dose through an IV catheter over approximately 1 hour | Drug | Arm A |
Primary outcome
Relative bioavailability of GSK933776 after single dose SQ or IM administration as compared to IV infusion
Time frame: Blood samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of area under concentration time curve from time zero to infinity (AUC [0-infinity]) following single dose SQ and IM injection to intravenous (IV) infusion
Relative bioavailability of GSK933776 after repeat dose SQ administration as compared to IV infusion
Time frame: Blood samples will be collected at following time points: pre-dose, 6, 24, 48, 72, 96 and 120 hours post dose in each of the 4 dosing weeks and additionally at 216, 336, 504, 672, 1344 and 2016 hours post last dose
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of AUC (0-infinity) following SQ repeat dose injections to intravenous (IV) infusion
15 secondary outcomes
Composite of PK parameters of GSK933776 following single dose IM and SQ administration as compared to IV administration
Time frame: Samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose
Composite of PK parameters of GSK933776 following repeat dose SQ administration as compared to IV administration
Time frame: Blood samples will be collected at following time points: pre-dose, 6, 24, 48, 72, 96 and 120 hours post dose in each of the 4 dosing weeks and additionally at 216, 336, 504, 672, 1344 and 2016 hours post last dose.
Number of participants with adverse events as a measure of safety and tolerability following single dose administration
Time frame: Up to 113 days
Clinical observation following IV, SQ and IM single dose administration as a measure of safety and tolerability
Time frame: Up to 134 days
Clinical observation following IV, SQ and IM repeat dose administration as a measure of safety and tolerability
Time frame: Up to 113 days
Vital sign measurement following single dose administration as a measure of safety and tolerability
Time frame: Up to 134 days
Vital sign measurement following repeat dose administration as a measure of safety and tolerability
Time frame: Up to 134 days
Electrocardiogram (ECG) measurement following single dose administration to assess safety and tolerability
Time frame: Up to 113 days
ECG measurement following repeat dose administration to assess safety and tolerability
Time frame: Up to 134 days
Clinical laboratory parameters assessment following single dose administration as a measure of safety and tolerability
Time frame: Up to 113 days
Clinical laboratory parameters assessment following repeat dose administration as a measure of safety and tolerability
Time frame: Up to 134 days
Plasma concentrations of GSK933776, total amyloid beta (AB), total AB fragments, as well as unbound concentrations of AB, fragments containing the epitope 1-22, as data permit following single dose administrationof GSK933776
Time frame: Up to 113 days
Plasma concentration of GSK933776, AB, total AB fragments, as well as unbound concentrations of AB, fragments containing the epitope 1-22, as data permit following repeat dose administration
Time frame: Up to 134 days
Presence of antibodies to GSK933776 in serum samples following single dose administration of GSK933776
Time frame: Up to 113 days
Presence of antibodies to GSK933776 in serum samples following repeat dose administration
Time frame: Up to 134 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 15 May 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 116891 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GSK933776 for SQ administration, GSK933776 for IM administration and GSK933776 for IV administration in people with Atrophy, Geographic, 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 6 inclusion and 15 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 15 May 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?
Relative bioavailability of GSK933776 after single dose SQ or IM administration as compared to IV infusion (time frame: Blood samples will be collected at following time points: pre-dose and at (0.25, 0.5, 0.75, 1, 2, 4 hours only for IV infusion), 6, 24, 48, 72, 96, 120, 216, 336, 504, 672, 1344 and 2016 hours post dose). The study lists 2 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 15 May 2017.