Systemic Lupus ErythematosusPhase 1NCT01516450
Japanese phase1 Study of Belimumab (IV vs SC)
A Phase 1 study testing GSK1550188 IV and GSK1550188 SC in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- GSK1550188 IV and GSK1550188 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- 26 Dec 2011to 11 Apr 2012
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. Rationale: Set for the appropriate selection of healthy males
- Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- Body weight greater than and equal to 50.0 kg and BMI within the range 18.5 more than and equal to - less than 25.0 kg/m2. Rationale: To include those who have a standard figure based on the obesity criteria of the Obesity Association in Japan, these ranges are established
- Non-smoker or ex-smoker having ceased smoking for at least 6 months. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- AST, ALT, alkaline phosphatase and total bilirubin less than and equal to ULN at screening. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Rationale: Set in consideration of ethics of the study in accordance with GCP.
- Single QTc [QTcF] less than 450 msec. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
Who cannot join
- A positive test for syphilis, Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B core antibody, or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 antibody at screening. Rationale: Set for the appropriate selection of healthy subjects and in consideration of safety of the staff that handle or measure the blood samples.
- A positive pre-study drug screen at screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the administration of study medication of this study. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Exposure to more than four new chemical entities within 12 months prior to the dosing day. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- The subject planned to concurrently participate in another clinical study or post-marketing study. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
Show all 18Show fewer
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the administration of study medication. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy excluding pollen allergy without current symptoms. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Where participation in the study would result in donation of blood or blood products in excess of 400 mL within 4 month or 200 mL within 2 months.
- Unwillingness or inability to follow the procedures outlined in the protocol. Rationale: Set to secure study quality
- Subject is mentally or legally incapacitated. Rationale: Set to secure study quality
- Subjects with ECG results considered clinically significant by the investigator. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Subjects with a supine systolic blood pressure less than 90 mmHg or greater than140 mmHg and/or a supine diastolic blood pressure less than 55 mmHg or greater than 90 mmHg and/or systolic blood pressure drop from supine to standing of greater than 30 mmHg. Rationale: Set in consideration of subjects' safety related to the IV route of administration.
- Immunoglobulin (M, A, G) level is less than LLN at screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of anaphylactic reaction to any food, drug, or insect bite/sting. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of allergic reaction to parenteral administration of contrast agents, foreign proteins, or monoclonal antibodies. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of B cell targeted therapy (rituximab, other anti-CD20agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, LY2127399 [anti-BAFF] or GSK1550188) at any time. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of any infection requiring hospitalization or treatment with antivirals or antibiotics, or vaccination within 30 days prior to administration of study medication. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Parallel, Single Dose Study to Investigate Safety and Pharmacokinetics Following Intravenous Administration and Subcutaneous Administration of GSK1550188 in Healthy Japanese Males
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- GSK1550188 IV, GSK1550188 SC
- Keywords
- GSK1550188, belimumab, SLE, healthy, Japanese, pharmacokinetics, safety
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1550188 IVDrug
Single IV dose of belimumab 200 mg
GSK1550188 SCDrug
Single SC dose of belimumab 200mg
| Study group | Role | What they receive |
|---|---|---|
| GSK1550188 200mg for SC | Active comparator | Single SC dose of belimumab 200mg Receives: Drug: GSK1550188 SC |
| GSK1550188 200mg for IV | Active comparator | Single IV dose of belimumab 200 mg Receives: Drug: GSK1550188 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Vital signs
Systolic and diastolic blood pressure, pulse rate, body temperature
Measured: Day1-Day71
Change from baseline of biomarkers
CD20+, immunoglobulin
Measured: Day-1 - Day71
Immunogenicity
Presence of anti belimumab antibody
Measured: Day0 - Day71 (if necessary, 6-month)
Change from baseline of other safety parameters after single intravenous and subcutaneous administration
ECGs, clinical laboratory test, local tolerance evaluation (injection site), and adverse events
Measured: Day-1 - Day71
Secondary outcomes (2)
Composite (or profile) of pharmacokinetics after single intravenous administration
Percentage of AUC(0-inifinity) obtained by extrapolation (%AUCex), Time of last quantifiable concentration (tlast), Systemic clearance of parent drug (CL), Volume of distribution after IV/SC administration (Vz), Volume of distribution after IV administration at steady state (Vss), Terminal phase rate constant (λz), Mean residence time(MRT)
Measured: Day1-Day71
Composite (or profile) of pharmacokinetics after subcutaneous administration
Area under concentration-time curve (AUC) 0-7days, AUC 0-28 days, Percentage of AUC(0-infinity) obtained by extrapolationAUC(0-infinity) (%AUCex), tlast, Apparent clearance following subcutaneous dosing (CL/F), Volume of distribution after IV/SC administration (Vz)/F, λz, MRT
Measured: Day-1 - Day71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study start26 Dec 2011
- Primary completion11 Apr 2012
- Study completion11 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01516450
- Sponsor's protocol ID
- 116119
- Status last verified
- Jun 2017
- First submitted
- 21 Dec 2011
- Last updated
- 12 Jun 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.
Publications
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
PubMed 34741731Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
PubMed 34628605
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Parallel, Single Dose Study to Investigate Safety and Pharmacokinetics Following Intravenous Administration and Subcutaneous Administration of GSK1550188 in Healthy Japanese Males
- ClinicalTrials.gov ID
- NCT01516450
- Acronym / sponsor ID
- 116119
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- GSK1550188, belimumab, SLE, healthy, Japanese, pharmacokinetics, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2011 (actual)
- Primary completion
- 11 Apr 2012 (actual)
- Study completion
- 11 Apr 2012 (actual)
- First posted
- 24 Jan 2012 (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 an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK1550188 200mg for SC | Active comparator | Drug: GSK1550188 SCSingle SC dose of belimumab 200mg |
| GSK1550188 200mg for IV | Active comparator | Drug: GSK1550188 IVSingle IV dose of belimumab 200 mg |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. Rationale: Set for the appropriate selection of healthy males
- Japanese healthy male between 20 and 55 years of age inclusive, at the time of signing the informed consent. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- Body weight greater than and equal to 50.0 kg and BMI within the range 18.5 more than and equal to - less than 25.0 kg/m2. Rationale: To include those who have a standard figure based on the obesity criteria of the Obesity Association in Japan, these ranges are established
- Non-smoker or ex-smoker having ceased smoking for at least 6 months. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
- AST, ALT, alkaline phosphatase and total bilirubin less than and equal to ULN at screening. Rationale: Set for the appropriate evaluation of safety and pharmacokinetics of GSK1550188 in healthy Japanese males
Key exclusion criteria (18 listed)
- A positive test for syphilis, Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B core antibody, or positive Hepatitis C antibody, HIV antigen /antibody, HTLV-1 antibody at screening. Rationale: Set for the appropriate selection of healthy subjects and in consideration of safety of the staff that handle or measure the blood samples.
- A positive pre-study drug screen at screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- The subject had participated in a clinical study or post-marketing study with an investigational or a non-investigational product during the previous 4 months preceding the administration of study medication of this study. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
- Exposure to more than four new chemical entities within 12 months prior to the dosing day. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188.
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 |
|---|---|---|
| GSK1550188 IVSingle IV dose of belimumab 200 mg | Drug | GSK1550188 200mg for IV |
| GSK1550188 SCSingle SC dose of belimumab 200mg | Drug | GSK1550188 200mg for SC |
Primary outcome
Change from baseline of Vital signs
Time frame: Day1-Day71
Systolic and diastolic blood pressure, pulse rate, body temperature
Change from baseline of biomarkers
Time frame: Day-1 - Day71
CD20+, immunoglobulin
Immunogenicity
Time frame: Day0 - Day71 (if necessary, 6-month)
Presence of anti belimumab antibody
Change from baseline of other safety parameters after single intravenous and subcutaneous administration
Time frame: Day-1 - Day71
ECGs, clinical laboratory test, local tolerance evaluation (injection site), and adverse events
2 secondary outcomes
Composite (or profile) of pharmacokinetics after single intravenous administration
Time frame: Day1-Day71
Composite (or profile) of pharmacokinetics after subcutaneous administration
Time frame: Day-1 - Day71
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 12 Jun 2017.
- Derived from this study: PubMed 34741731Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
- Derived from this study: PubMed 34628605Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
- 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 116119 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 GSK1550188 IV and GSK1550188 SC in people with Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in Japan.
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 18 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 12 Jun 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 Japan. 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?
Change from baseline of Vital signs (time frame: Day1-Day71). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516450, which also lists 2 linked publications.
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 12 Jun 2017.