Stopped: Further development of GSK3494245 has been halted based on assessment of clinical data indicating that predicted efficacious doses cannot be achieved in line with dosing requirements outlined in the target product profile for the proposed indication.
This study is the first to test GSK3494245 in humans, to evaluate its safety, tolerability, and pharmacokinetics (PK) after a single dose. It involves 3 groups of participants and has a crossover design where each participant received a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. The first 2 Cohorts received up to 3 increasing doses of the drug and 1 dose of a placebo under fasted conditions, within each period, according to the randomization schedule, in a blinded manner. Cohort 3 is comprised of a 2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1 regimen under fed then fasted conditions in a 1:1 ratio.
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Number of Participants With Adverse Events (AEs)
Timeframe: From Day 1 (first dose) up to 14 days post last dose in each treatment period
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: From the signing of the informed consent form (a period starting up to 28 days before the first dose on Day 1) to up to 14 days after the last dose of each treatment period
Number of Participants With Treatment Emergent AEs (TEAEs) and Treatment Emergent SAEs
Timeframe: From Day 1 (first dose) up to 2 days post last dose in each treatment period
Summary of Change From Baseline in Hematology Parameters: Basophils, Neutrophils, Eosinophils, Lymphocytes, Monocytes and Platelets
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Volume
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Erythrocytes and Reticulocytes
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Hemoglobin
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Hematology Parameters: Hematocrit and Reticulocytes
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT)
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Albumin, Protein
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Calcium Corrected for Albumin, Glucose, Lactic Acid, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, and Urea
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: C-reactive Protein (CRP)
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Clinical Chemistry Parameters: pH
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Number of Participants With Worst-case Urinalysis Results
Timeframe: From Day 1 up to 14 Days post last dose
Summary of Change From Baseline in Physical Examinations: Body Mass Index (BMI)
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Vital Signs: Respiratory Rate
Timeframe: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Vital Signs: Supine Diastolic Blood Pressure, Supine Systolic Blood Pressure
Timeframe: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Vital Signs: Supine Pulse Rate
Timeframe: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Vital Signs: Tympanic Membrane Temperature
Timeframe: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day 3 (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in Physical Examinations: Weight
Timeframe: At Day 2 and Day 4 in each treatment period compared to Baseline
Summary of Change From Baseline in Electrocardiogram (ECG) Parameters: Heart Rate
Timeframe: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Summary of Change From Baseline in ECG Parameters: PR Interval, QRS Interval, QT Interval, Corrected QT (QTc) Interval, QT Interval Corrected Using Bazett's Formula, QT Interval Corrected, Using Fridericia's Formula
Timeframe: At Day 1 (30 minutes, 1 hour [h], 1.5h, 2h, 2.5h, 4h, 8h, 12h), Day 2 (24h), Day (48h), and Day 4 in each treatment period compared to Baseline (pre-dose)
Number of Participants With Abnormal Cardiac Telemetry Findings
Timeframe: Up to 24 hours post first dose on Day 1