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 range

18 Years – 50 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 50 Years

Sex

ALL

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