A First Time in Human (FTIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK3884464 in Healthy Participants

• Status: Recruiting
• Trial end date: 2022-10-18
• Target enrollment: 0
• Participant gender: All

Summary

This will be a FTIH study which aims to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of GSK3884464 administered to healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• Healthy as determined by the experienced investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring/assessment.

• Part 1: Body weight greater than or equal to (>=)50 kilograms (kg), body mass index (BMI) >=18 and less than or equal to (<=)30 kilograms per square meter (kg/m^2) (inclusive). Part 2: Body weight >=50 kg, BMI >=22 and <=30 kg/m^2 (inclusive).

• Participants with 18 to 50 years of age inclusive at the time of signing the informed consent.

• Male or females of non-childbearing potential.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion criteria:

• History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (Gastroesophageal reflux disease [GERD], nausea, vomiting or dysphagia), 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.

• History of current or past significant renal diseases.

• Clinically significant high blood pressure and/or history of hypertension as determined by the investigator.

• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.

• Breast cancer within the past 10 years.

• Any clinically relevant abnormality on the screening medical assessments.

• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• Unable to refrain from the use of prescription or non-prescription drug.

• A positive laboratory confirmation of Coronavirus Disease-2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19.

• Participants with Glycated hemoglobin (HbA1c) greater than (>)48 millimoles per mol (mmol/mol) at screening.

• Presence of Hepatitis B surface antigen at screening.

• Positive Hepatitis C antibody test result at screening.

• Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.

• Positive pre-study drug/alcohol screen.

• Positive Human immunodeficiency virus (HIV) antibody test.

• Screening urine albumin to creatinine ratio >30 milligrams/grams (mg/gm) (>3 mg/mmol).

• Regular use of known drugs of abuse.

• Regular alcohol consumption within six months prior to the study defined as: An average weekly intake of >=14 units for males >=14 units for females. One unit is equivalent to 8 gm of alcohol: a half-pint (approximately 240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

• Smokelyzer test levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (for example [e.g.] nicotine patches or vaporizing devices) within 3 months prior to screening.

• Participants with a history or current evidence of depression, bipolar disorder, suicidal ideation and behavior, or a lifetime history of suicide attempt will be excluded.