GSK Investigational Site
Cambridge, CB2 0GG, United Kingdom
NCT Number: NCT06171113
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Cambridge, CB2 0GG, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Doses administrated orally with 240 mL of water.
Doses administrated orally with 240 mL of water.
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
Mild SAE = a type of adverse event (AE) that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Time frame: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
Mild SAE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
Mild AE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate AE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe AE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: Part B: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Time frame: At Day 1 and at Day 3
Time frame: At Day 1 and at Day 3
GlaxoSmithKline
Industry
A Phase 1, Randomised, Double Blind Placebo-controlled, First Time in Human Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Oral Doses and Food Effect of GSK4024484 in Healthy Adult Participants.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02014727
Infections, Malaria
Ouagadougou, Burkina Faso
View Trial DetailsNCT07027722
Antimalarials, Artemisinins
Saint-Denis, France
View Trial DetailsNCT04839900
Infections, Malaria
Chadiza, Eastern Provice, Zambia
View Trial DetailsNCT04709692
Infections, Malaria
Iquitos, Loreto, Peru
View Trial Details