Autoimmune DiseasesPhase 1NCT03590613

Phase I Study of GSK2982772 in Japanese Healthy Male Participants

A Phase 1 study testing GSK2982772 in people with Autoimmune Diseases, run by GlaxoSmithKline at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for: Autoimmune Diseases
What is being tested?: GSK2982772
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteJapan
Study dates: 19 Jul 2018to 26 Sep 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subject must be 20 to 64 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the Investigators based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigators in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18.5-24.9 kg/meter square (inclusive).
Japanese male subjects must agree to use contraception as detailed in protocol during the treatment period and until follow up visit.
Capable of giving informed consent as described in the protocol.

Who cannot join

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Abnormal blood pressure as determined by the investigators.
Symptomatic herpes zoster within 3 months prior to screening.
Evidence of active or latent Tuberculosis (TB) as documented by medical history and examination, chest X-rays (anterior and lateral), and TB testing (T Spot. TB)
ALT >1.5 times upper limit of normal (ULN).
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

Show all 22Show fewer

Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of active infections within 14 days of first receiving study medication.
Corrected Q-T interval (QTc) obtained using the Fridericia's formula (QTcF) > 450 millisecond.
History or diagnosis of obstructive sleep apnoea, or a significant respiratory disorder. Childhood asthma that was fully resolved is permitted.
History of active Suicidal Ideation Behavior within the past 6 months or any history of attempted suicide in a subject's lifetime.
History or current evidence of febrile seizures, epilepsy, convulsions, significant head injury, or other significant neurologic conditions.
Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing; live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
History of donation of blood or blood products >= 400 mL within 3 months or >= 200 mL within 1 month prior to screening.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
The subject has participated in a other clinical study or other medical research within 4 months prior to the first dosing day in the current study.
Subject is positive Serological test for syphilis Rapid Plasma Reagin [RPR] and Treponema pallidum [TP]), Tuberculosis, human immunodeficiency virus (HIV) Antigen/Antibody, Hepatitis B surface antigen (HbsAg), Hepatitis C virus (HCV) antibody, or Human T-cell leukemia virus type 1 (HTLV-1) antibody at screening.
Positive pre-study drug screen.
Regular use of known drugs of abuse.
Regular alcohol consumption within 6 months prior to the study defined as: for an average weekly intake of > 14 units for males. One unit is equivalent to 350 mL of beer, 150 mL of wine or 45 mL of 80 proof distilled spirits.
Smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigators or GSK Medical Monitor, contraindicates participation in the study.

Trial locations and contacts

1 site in 1 country.

Japan1 site

GSK Investigational Site
Fukuoka, 812-0025

Other trials in Japan

About this study

Official title: A Single-centre, Randomized, Double-blind, Dose-ascending, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral TID Doses (One Day) of GSK2982772 in Japanese Healthy Male Subjects

The study plans to enroll approximately 12 subjects. The main objective of the study is to assess the safety, tolerability and pharmacokinetics (PK) of the three times a day (TID), dosing of GSK2982772, in Japanese healthy male subjects. The study will comprise of four study periods each at least 7 days in duration with subjects in-house for 4 nights (through 72 hrs after the first dose). During each treatment period (TP), subjects will be admitted to the unit the day before dosing and will be discharged after completion of the 72 hours post-dose assessments. There will be a washout of atleast 7-days between the TP doses for each individual, post which there will be 7-days follow-up. The dose range proposed in this study is based on a low starting dose, which will be escalated to the highest dose that is intended for the Phase 2b dose range study. The decision to proceed to the next dose-level, of GSK2982772 within the study will be made by principal investigator and GSK Medical Monitor per each dosing periods. The study duration is approximately 22 weeks.

Conditions: Autoimmune Diseases
Being tested: GSK2982772, Placebo
Keywords: Sentinel-dosing, GSK2982772, Japnese, Dose-ascending, Crossover, Healthy
Medical subject headings: Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2982772Drug
GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route
PlaceboDrug
Placebo matching GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route.

Study groups in NCT03590613
Study group	Role	What they receive
Sequence 1: Placebo TID then 60 TID then 120 TID then 240 TID	Experimental	The eligible subjects in this arm will receive placebo TID in TP1, GSK2982772 60 mg TID in TP2, GSK2982772 120mg TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject. Receives: Drug: GSK2982772; Drug: Placebo
Sequence 2: 60 TID then Placebo TID then 120 TID then 240 TID	Experimental	The eligible subjects in this arm will receive GSK2982772 60 mg TID in TP1, placebo TID in TP2, GSK2982772 120mg TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject. Receives: Drug: GSK2982772; Drug: Placebo
Sequence 3: 60 TID then 120 TID then Placebo TID then 240 TID	Experimental	The eligible subjects in this arm will receive GSK2982772 60 mg TID in TP1, GSK2982772 120mg TID in TP2, placebo TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject. Receives: Drug: GSK2982772; Drug: Placebo
Sequence 4: 60 TID then 120 TID then 240 TID then Placebo TID	Experimental	The eligible subjects in this arm will receive GSK2982772 60 mg TID in TP1, GSK2982772 120mg TID in TP2, GSK2982772 240 mg TID in TP3 and placebo TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject. Receives: Drug: GSK2982772; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants who have received at least one dose of study treatment. This population was used for the safety analyses.
Measured: From the day of first dose to 39 days
Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for the analysis of clinical chemistry parameters including: glucose, calcium, cholesterol, chloride, high density lipoprotein (HDL) cholesterol, potassium, low density lipoprotein (LDL) cholesterol, phosphate, sodium, triglycerides and urea. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each treatment period
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected for the analysis of clinical chemistry parameters including: albumin and protein. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrognase (LDH)
Blood samples were collected for the analysis of clinical chemistry parameters including: ALP, ALT, AST, CK, GGT and LDH. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Clinical Chemistry Parameter: Amylase
Blood samples were collected for the analysis of clinical chemistry parameter: amylase. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine and Urate (Uric Acid)
Blood samples were collected for the analysis of clinical chemistry parameters:direct bilirubin, bilirubin, creatinine and urate. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Clinical Chemistry Parameter: C-reactive Protein (CRP) of TID Doses for One Day of GSK2982772
Blood samples were collected for the analysis of clinical chemistry parameter: CRP. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCH. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV)
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Blood samples were collected for the analysis of hematology parameter: percentage reticulocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameters: Platelets and Leukocytes of TID Doses for One Day of GSK2982772
Blood samples were collected for the analysis of hematology parameters including platelet count and leukocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Hematology Parameters of TID Doses for One Day of GSK2982772
Blood samples were collected for the analysis of hematology parameters including neutrophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, eosinophils/leukocytes and basophils/leukocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Change From Baseline in Urine Specific Gravity
Urine samples were collected for analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 72 hours at each Treatment Period
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
Urine samples were collected to assess urine bilirubin, urine glucose, urine ketones, urine occult blood, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-) and trace (+-) indicating proportional concentrations in the urine sample.
Measured: At 72 hours of each Treatment Period
Change From Baseline in Electrocardiogram (ECG) Finding: Mean Heart Rate
Full 12-lead ECGs were recorded in participant using an automated ECG machine. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Change From Baseline in ECG Findings of TID Doses for One Day of GSK2982772
Full 12-lead ECGs were recorded in participants using an automated ECG machine and measured PR, QRS, QT and QTcF intervals. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Number of Participants With Abnormal Not Clinically Significant Cardiac Telemetry
Continuous cardiac telemetry was performed and number of participants with abnormal clinically significant and not clinically significant values are presented.
Measured: Up to 24 hours at each Treatment Period
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each treatment period
Change From Baseline in Pulse Rate of TID Doses for One Day of GSK2982772
Pulse rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Change From Baseline in Body Temperature of TID Doses for One Day of GSK2982772
Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Number of Participants With Abnormal Neurological Examinations of TID Doses for One Day of GSK2982772
Neurological examinations including: mental status, gait, balance, coordination, cranial nerves, motor power, reflexes, and sensory system (light touch and pain) were assessed in participants specified time points.
Measured: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period

Secondary outcomes (4)

Area Under the Plasma Drug Concentration Versus Time Curve Over 24 Hours (AUC[0-24]) and AUC Over Each Dose Interval of TID Doses for One Day of GSK2982772
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24) and AUC over each dose: AUC(0-7), AUC (7-14) and AUC (14-24) after the administration of TID doses of GSK2982772. Pharmacokinetic analysis was conducted using standard non-compartmental methods. All participants in the safety population for whom a pharmacokinetic sample has been obtained and analyzed was included in the pharmacokinetic population.
Measured: Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours, 7 hours 20 minutes, 7 hours 40 minutes, 8, 8.5, 9, 10, 12, 14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15, 15.5, 16, 17, 19, 22 and 24 hours post-dose at each Treatment Period
Maximum Observed Plasma Concentration (Cmax) and Observed Trough Drug Plasma Concentrations Following Each TID Doses for One Day of GSK2982772
Blood samples were collected from participants at indicated time points and analyzed for Cmax and observed trough drug plasma concentrations: C0, C7, C14 and C24 after the administration of TID doses of GSK2982772.
Measured: Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period
Terminal Half Life (t1/2) After the Third TID Dose for One Day of GSK2982772
Blood samples were collected from participants at indicated time points and t1/2 was analyzed after the administration of third TID dose of GSK2982772.
Measured: Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period
Time to Maximum Observed Plasma Drug Concentration (Tmax) of Each TID Doses for One Day of GSK2982772
Blood samples were collected from participants at indicated time points and Tmax was analyzed after the administration of TID doses of GSK2982772.
Measured: Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 201826 Sep 2018

First posted18 Jul 2018
Study start19 Jul 2018
Primary completion21 Sep 2018
Study completion26 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autoimmune DiseasesStudies 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
Model description: Study will comprise of four TPs, each of at least 7 days in duration with subjects in-house for 4 nights (through 72 hours after the first dose). During each TP, subjects will be admitted to the unit, day before dosing and will be discharged after completion of 72 hours post-dose assessments. dose will be administered TID, in an ascending manner. Every individual subject will receive placebo and GSK2982772 (60, 120,240 mg TID) as per assigned sequence. For TID dosing, GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hour (the second dosing) and 14 hour (the third dosing) on Day 1 in each period. On Day 1, subjects will fast 8hour overnight prior to first dose. breakfast will be served approximately 2hour after first dose. Lunch and dinner will be served between 2 to 3hour prior to second and third doses, respectively. A washout of atleast 7-days between the TP doses for each individual subject.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03590613
Sponsor's protocol ID: 205037
Status last verified: Sep 2023
First submitted: 6 Jul 2018
Last updated: 4 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

Tompson DJ, Davies C, Scott NE, Cannons EP, Kostapanos M, Gross AS, Powell M, Ino H, Shimamura R, Ogura H, Nagakubo T, Igarashi H, Nakano A. Comparison of the Pharmacokinetics of RIPK1 Inhibitor GSK2982772 in Healthy Western and Japanese Subjects. Eur J Drug Metab Pharmacokinet. 2021 Jan;46(1):71-83. doi: 10.1007/s13318-020-00652-2.
PubMed 33165774

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-centre, Randomized, Double-blind, Dose-ascending, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral TID Doses (One Day) of GSK2982772 in Japanese Healthy Male Subjects
ClinicalTrials.gov ID: NCT03590613
Acronym / sponsor ID: 205037
Conditions: Autoimmune Diseases
Keywords: Sentinel-dosing, GSK2982772, Japnese, Dose-ascending, Crossover, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Jul 2018 (actual)
Primary completion: 21 Sep 2018 (actual)
Study completion: 26 Sep 2018 (actual)
First posted: 18 Jul 2018 (actual)
Results: Posted 17 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
Model description: Study will comprise of four TPs, each of at least 7 days in duration with subjects in-house for 4 nights (through 72 hours after the first dose). During each TP, subjects will be admitted to the unit, day before dosing and will be discharged after completion of 72 hours post-dose assessments. dose will be administered TID, in an ascending manner. Every individual subject will receive placebo and GSK2982772 (60, 120,240 mg TID) as per assigned sequence. For TID dosing, GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hour (the second dosing) and 14 hour (the third dosing) on Day 1 in each period. On Day 1, subjects will fast 8hour overnight prior to first dose. breakfast will be served approximately 2hour after first dose. Lunch and dinner will be served between 2 to 3hour prior to second and third doses, respectively. A washout of atleast 7-days between the TP doses for each individual subject.

Arm	Type	Receives
Sequence 1: Placebo TID then 60 TID then 120 TID then 240 TID	Experimental	Drug: GSK2982772, Drug: PlaceboThe eligible subjects in this arm will receive placebo TID in TP1, GSK2982772 60 mg TID in TP2, GSK2982772 120mg TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject.
Sequence 2: 60 TID then Placebo TID then 120 TID then 240 TID	Experimental	Drug: GSK2982772, Drug: PlaceboThe eligible subjects in this arm will receive GSK2982772 60 mg TID in TP1, placebo TID in TP2, GSK2982772 120mg TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject.
Sequence 3: 60 TID then 120 TID then Placebo TID then 240 TID	Experimental	Drug: GSK2982772, Drug: PlaceboThe eligible subjects in this arm will receive GSK2982772 60 mg TID in TP1, GSK2982772 120mg TID in TP2, placebo TID in TP3 and GSK2982772 240 mg TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject.
Sequence 4: 60 TID then 120 TID then 240 TID then Placebo TID	Experimental	Drug: GSK2982772, Drug: PlaceboThe eligible subjects in this arm will receive GSK2982772 60 mg TID in TP1, GSK2982772 120mg TID in TP2, GSK2982772 240 mg TID in TP3 and placebo TID in TP4. GSK2982772 or placebo will be administered at 0 hour (the first dosing), 7 hours (the second dosing) and 14 hours (the third dosing) on Day 1 in each TP. Subjects will fast overnight for 8 hours before first dose. Each TP will be followed by a washout period of at least 7 days, for each subject.

Who may qualify

Ages: 20 to 64 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subject must be 20 to 64 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the Investigators based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and ECG. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigators in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18.5-24.9 kg/meter square (inclusive).
Japanese male subjects must agree to use contraception as detailed in protocol during the treatment period and until follow up visit.
Capable of giving informed consent as described in the protocol.

Key exclusion criteria (22 listed)

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Abnormal blood pressure as determined by the investigators.
Symptomatic herpes zoster within 3 months prior to screening.
Evidence of active or latent Tuberculosis (TB) as documented by medical history and examination, chest X-rays (anterior and lateral), and TB testing (T Spot. TB)
ALT >1.5 times upper limit of normal (ULN).

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
GSK2982772GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route	Drug	Sequence 1: Placebo TID then 60 TID then 120 TID then 240 TID, Sequence 2: 60 TID then Placebo TID then 120 TID then 240 TID, Sequence 3: 60 TID then 120 TID then Placebo TID then 240 TID, Sequence 4: 60 TID then 120 TID then 240 TID then Placebo TID
PlaceboPlacebo matching GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route.	Drug	Sequence 1: Placebo TID then 60 TID then 120 TID then 240 TID, Sequence 2: 60 TID then Placebo TID then 120 TID then 240 TID, Sequence 3: 60 TID then 120 TID then Placebo TID then 240 TID, Sequence 4: 60 TID then 120 TID then 240 TID then Placebo TID

Primary outcome

Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the day of first dose to 39 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants who have received at least one dose of study treatment. This population was used for the safety analyses.
Change From Baseline in Clinical Chemistry Parameters
Time frame: Baseline (Day -1) and at 72 hours at each treatment period
Blood samples were collected for the analysis of clinical chemistry parameters including: glucose, calcium, cholesterol, chloride, high density lipoprotein (HDL) cholesterol, potassium, low density lipoprotein (LDL) cholesterol, phosphate, sodium, triglycerides and urea. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of clinical chemistry parameters including: albumin and protein. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrognase (LDH)
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of clinical chemistry parameters including: ALP, ALT, AST, CK, GGT and LDH. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Clinical Chemistry Parameter: Amylase
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of clinical chemistry parameter: amylase. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine and Urate (Uric Acid)
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of clinical chemistry parameters:direct bilirubin, bilirubin, creatinine and urate. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Clinical Chemistry Parameter: C-reactive Protein (CRP) of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of clinical chemistry parameter: CRP. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameter: Hematocrit
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameter: Hemoglobin
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCH. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV)
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameter: Erythrocytes
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameter: percentage reticulocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameters: Platelets and Leukocytes of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameters including platelet count and leukocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Hematology Parameters of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Blood samples were collected for the analysis of hematology parameters including neutrophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, eosinophils/leukocytes and basophils/leukocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Urine Potential of Hydrogen (pH)
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Urine Specific Gravity
Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period
Urine samples were collected for analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
Time frame: At 72 hours of each Treatment Period
Urine samples were collected to assess urine bilirubin, urine glucose, urine ketones, urine occult blood, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-) and trace (+-) indicating proportional concentrations in the urine sample.
Change From Baseline in Electrocardiogram (ECG) Finding: Mean Heart Rate
Time frame: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Full 12-lead ECGs were recorded in participant using an automated ECG machine. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in ECG Findings of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Full 12-lead ECGs were recorded in participants using an automated ECG machine and measured PR, QRS, QT and QTcF intervals. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Number of Participants With Abnormal Not Clinically Significant Cardiac Telemetry
Time frame: Up to 24 hours at each Treatment Period
Continuous cardiac telemetry was performed and number of participants with abnormal clinically significant and not clinically significant values are presented.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each treatment period
Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Pulse Rate of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Pulse rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Change From Baseline in Body Temperature of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Number of Participants With Abnormal Neurological Examinations of TID Doses for One Day of GSK2982772
Time frame: Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period
Neurological examinations including: mental status, gait, balance, coordination, cranial nerves, motor power, reflexes, and sensory system (light touch and pain) were assessed in participants specified time points.

4 secondary outcomes

Area Under the Plasma Drug Concentration Versus Time Curve Over 24 Hours (AUC[0-24]) and AUC Over Each Dose Interval of TID Doses for One Day of GSK2982772
Time frame: Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours, 7 hours 20 minutes, 7 hours 40 minutes, 8, 8.5, 9, 10, 12, 14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15, 15.5, 16, 17, 19, 22 and 24 hours post-dose at each Treatment Period
Maximum Observed Plasma Concentration (Cmax) and Observed Trough Drug Plasma Concentrations Following Each TID Doses for One Day of GSK2982772
Time frame: Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period
Terminal Half Life (t1/2) After the Third TID Dose for One Day of GSK2982772
Time frame: Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period
Time to Maximum Observed Plasma Drug Concentration (Tmax) of Each TID Doses for One Day of GSK2982772
Time frame: Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period

Results and safety

Results posted to the registry on 17 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A: PBO TID /60mg TID /120mg TID /240mg TID	3	3
Treatment Sequence B: 60mg TID /PBO TID /120mg TID /240mg TID	3	3
Treatment Sequence C: 60mg TID/ 120mg TID/ PBO TID/ 240mg TID	3	3
Treatment Sequence D: 60mg TID /120mg TID /240mg TID /PBO TID	3	3

Primary outcome: Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From the day of first dose to 39 days. Count of participants. Unit: Participants

Measure	Placebo n = 12	GSK2982772 60 mg n = 12	GSK2982772 120 mg n = 12	GSK2982772 240 mg n = 12
Any AE	0	1	0	0
Any SAE	0	0	0	0

Population analysed: Safety Population.

Primary outcome: Change From Baseline in Clinical Chemistry Parameters

Time frame: Baseline (Day -1) and at 72 hours at each treatment period. Mean (Standard Deviation). Unit: Millimoles per liter

Measure	Placebo n = 12	GSK2982772 60 mg n = 12	GSK2982772 120 mg n = 12	GSK2982772 240 mg n = 12
Glucose	-0.240543 (0.1426732)	-0.282176 (0.2348638)	-0.240543 (0.2902134)	-0.226666 (0.2554319)
Calcium	0.016633 (0.0683974)	0.058217 (0.0341987)	-0.022871 (0.0732901)	-0.004158 (0.1036024)
Cholesterol	0.000000 (0.2092177)	0.073270 (0.2657498)	0.015085 (0.3458001)	-0.049565 (0.3560217)
Chloride	1.1 (1.38)	0.2 (2.25)	1.2 (1.59)	0.6 (1.68)
HDL Cholesterol	-0.071115 (0.1097839)	-0.034480 (0.1070976)	-0.084045 (0.1046815)	-0.116370 (0.0578247)
Potassium	-0.06 (0.156)	0.01 (0.329)	0.03 (0.501)	-0.07 (0.419)
LDL Cholesterol	0.036635 (0.1670318)	0.101285 (0.1673953)	0.017240 (0.2663211)	-0.043100 (0.1926790)
Phosphate	0.064580 (0.0963795)	0.053817 (0.1210793)	0.002691 (0.1155721)	0.018836 (0.1366196)

Population analysed: Safety Population.

Primary outcome: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period. Mean (Standard Deviation). Unit: Grams per liter

Measure	Placebo n = 12	GSK2982772 60 mg n = 12	GSK2982772 120 mg n = 12	GSK2982772 240 mg n = 12
Albumin	-1.4 (2.64)	-0.4 (1.62)	-1.6 (2.47)	-2.5 (3.23)
Protein	-1.3 (3.96)	0.8 (2.12)	-2.1 (3.70)	-2.3 (4.27)

Population analysed: Safety Population.

Primary outcome: Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrognase (LDH)

Time frame: Baseline (Day -1) and at 72 hours at each Treatment Period. Mean (Standard Deviation). Unit: International units per liter

Measure	Placebo n = 12	GSK2982772 60 mg n = 12	GSK2982772 120 mg n = 12	GSK2982772 240 mg n = 12
ALP	-9.1 (17.32)	-6.8 (12.63)	-10.6 (14.41)	-9.0 (14.65)
ALT	-0.5 (3.66)	0.5 (2.47)	-2.2 (3.33)	-1.3 (4.59)
AST	-0.6 (2.68)	0.3 (1.76)	-1.8 (3.28)	-2.5 (6.64)
CK	-19.1 (14.95)	-34.2 (21.70)	-51.7 (48.61)	-39.6 (32.91)
GGT	-0.5 (0.67)	-0.5 (1.62)	-1.8 (2.93)	-1.5 (2.32)
LDH	-17.7 (9.76)	-11.3 (8.01)	-21.6 (14.92)	-21.3 (10.34)

Population analysed: Safety Population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs and SAEs were collected from the start of the treatment up to 39 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	0 of 12 (0%)	0 of 12
GSK2982772 60 mg	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
GSK2982772 120 mg	0 of 12 (0%)	0 of 12 (0%)	0 of 12
GSK2982772 240 mg	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33165774Tompson DJ, Davies C, Scott NE, Cannons EP, Kostapanos M, Gross AS, Powell M, Ino H, Shimamura R, Ogura H, Nagakubo T, Igarashi H, Nakano A. Comparison of the Pharmacokinetics of RIPK1 Inhibitor GSK2982772 in Healthy Western and Japanese Subjects. Eur J Drug Metab Pharmacokinet. 2021 Jan;46(1):71-83. doi: 10.1007/s13318-020-00652-2.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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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 GSK2982772 in people with Autoimmune Diseases, 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 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2023. 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?

Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the day of first dose to 39 days). The study lists 25 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 NCT03590613, which also lists 1 linked publication.

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 4 Oct 2023.