TerminatedPhase 1

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

Stopped: To allow for additional assessments from supplementary non-clinical activities.

United Kingdom27 participantsStarted 2021-09-20

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Serum troponin I or troponin-T greater than (\>) the upper limit of normal (ULN). * Lymphoma, le…

What they're measuring

Parts 1: Number of Participants With Adverse Events (AEs)

Timeframe: Up to Day 17

Parts 2: Number of Participants With Adverse Events (AEs)

Timeframe: Up to Day 29

Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

Timeframe: Up to Week 10

Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

Timeframe: Up to Week 10

Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

Timeframe: Up to Week 10

Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values

Timeframe: Up to Week 10

Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values

Timeframe: Up to Week 10

Trial details

NCT IDNCT05044325

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-05

Results submitted2023-11-03

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Parts 1: Number of Participants With Adverse Events (AEs)

Timeframe: Up to Day 17

Parts 2: Number of Participants With Adverse Events (AEs)

Timeframe: Up to Day 29

Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

Timeframe: Up to Week 10

Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

Timeframe: Up to Week 10

Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline

Timeframe: Up to Week 10

Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values

Timeframe: Up to Week 10

Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values

Timeframe: Up to Week 10