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
NCT05044325 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2024-05-02
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.
Conditions
Interventions
- DRUG
-
GSK3884464
GSK3884464 will be administered
- DRUG
-
Placebo to match GSK3884464 will be administered.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-20
- Primary Completion
- 2022-08-05
- Completion
- 2022-08-05
Countries
- United Kingdom
Study Locations
More Related Trials
-
A Study of CK-1827452 Infusion in Stable Heart Failure
NCT00624442 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
NCT00742508 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction
NCT03281122 ·Status: TERMINATED ·Phase: PHASE1
-
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
NCT03634969 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
NCT04216342 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure
NCT01120210 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
NCT01877915 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients
NCT03276728 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT06122779 ·Status: RECRUITING ·Phase: PHASE2
-
A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants
NCT03891108 ·Status: COMPLETED ·Phase: PHASE1
-
Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure
NCT04705987 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of CLR325 in Chronic Stable Heart Failure Patients.
NCT02696967 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers
NCT03494712 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of Istaroxime in Acute Decompensated Heart Failure Patients
NCT00838253 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure
NCT07218627 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
NCT01064037 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus
NCT04507347 ·Status: WITHDRAWN ·Phase: PHASE3
-
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
NCT03447990 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
NCT00259038 ·Status: COMPLETED ·Phase: PHASE2
-
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
NCT05991128 ·Status: UNKNOWN ·Phase: PHASE4
-
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
NCT02329184 ·Status: COMPLETED ·Phase: PHASE1
-
A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
NCT01357850 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
NCT04318093 ·Status: COMPLETED ·Phase: PHASE2
-
The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure
NCT02617446 ·Status: COMPLETED ·Phase: PHASE2
-
Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation
NCT06280768 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1