Last updated: 09/27/2023 12:10:17

Phase I study of GSK2982772 in Japanese healthy male participants

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GSK study ID

205037

See study documents

Clinicaltrials.gov ID

NCT03590613

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

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

Trial description: 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.

Primary purpose:

Treatment

Trial design:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Allocation:

Randomized

Primary outcomes:

Number of subjects with adverse events (AEs) and Serious adverse events (SAEs)

Timeframe: Up to Day 39

Number of subjects with abnormal hematology parameters

Timeframe: Up to Day 39

Number of subjects with abnormal clinical chemistry parameters

Timeframe: Up to Day 39

Number of subjects with abnormal urine parameters

Timeframe: Up to Day 39

Number of subjects with electrocardiogram (ECG) findings of potential clinical importance

Timeframe: Up to Day 39

Number of subjects with abnormal cardiac telemetry

Timeframe: Up to Day 39

Number of subjects with vital signs of PCI

Timeframe: Up to Day 39

Number of subjects with abnormal physical examination

Timeframe: Up to Day 39

Secondary outcomes:

Area under the plasma concentration-time curve (AUC) from time zero to 24 hours, AUC (0-24) for GSK2982772

Timeframe: 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, 24, 28, 32, 36, 48, 60 and 72 hours post-dose in each TP

AUC from time zero to Day 7 AUC (0-7), for GSK2982772

AUC from time zero to Day 7 to Day 14 AUC (7-14), for GSK2982772

AUC from time zero to Day 14 to Day 24 AUC (14-24) for GSK2982772

Maximum observed plasma drug concentration (Cmax) following each dose for GSK2982772

Time to maximum observed plasma drug concentration (Tmax) following each dose for GSK2982772

Terminal half-life (t1/2) following the third dose, for GSK2982772

Plasma drug concentration at pre-dose (C0)

Timeframe: Pre-dose on Day 1 of each TP

Plasma drug concentration at 7 hours after dosing (C7)

Timeframe: Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours

Plasma drug concentration at 14 hours after dosing (C14)

Timeframe: 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

Plasma drug concentration at 24 hours after dosing (C24)

Interventions:

Drug: GSK2982772

Drug: Placebo

Enrollment:

Observational study model:

Not applicable

Primary completion date:

2018-21-09

Time perspective:

Not applicable

Clinical publications:

Not applicable

Medical condition

Autoimmune Diseases

Product

GSK2982772

Collaborators

Not applicable

Study date(s)

July 2018 to September 2018

Type

Interventional

Phase

Participation criteria

Sex

Male

Age

20 - 64 years

Accepts healthy volunteers

Yes

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.

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.

Inclusion and exclusion criteria

Inclusion criteria:

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.

Exclusion criteria:

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%)
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 location(s)

Location

Status

Location

GSK Investigational Site

Fukuoka, Japan, 812-0025

Status

Study Complete

Study documents

Study report synopsis

Available language(s): English

Download document(s)

Protocol

Available language(s): English

Download document(s)

Statistical analysis plan

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Completed

Actual primary completion date

2018-21-09

Actual study completion date

2018-26-09

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information

Not applicable

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