A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGlaxoSmithKline
About this trial
This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring
Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m²) (inclusive)
Male, or female of non-childbearing potential (PONCBP)
Disqualifiers
Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
Abnormal blood pressure (as determined by the investigator)
Symptomatic herpes zoster within 3 months prior to screening
Trial design
Design model
Parallel
Treatments tested in this trial
GSK3862995B
DrugGSK3862995B will be administered.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: GSK3862995B Formulation AExperimental treatment 1 intervention
Group B: GSK3862995B Formulation BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B
Time frame
From pre-dose on Day 1 through Week 362
Maximum Observed Serum Concentration (Cmax) of GSK3862995B
Time frame
From pre-dose on Day 1 through Week 363
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame
Up to Week 494
Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings
Time frame
Up to Week 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov