BridgeMD
New treatment option for Malaria, Falciparum
Official title Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years
ClinicalTrials.gov ID: NCT07670377
What this study is testing
What is Midazolam (MDZ)?
Midazolam (MDZ) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malaria, falciparum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate whether GSK3772701 alters the pharmacokinetics (PK) of midazolam (MDZ), a standard probe substrate for the CYP3A4 enzyme. The findings are planned to be used to determine whether GSK3772701 acts as an inducer and/or inhibitor of CYP3A4 and will help guide recommendations for safe co-administration with CYP3A4 substrates.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Aged 18 to 55 years (inclusive), at the time of signing the informed consent form (ICF).
- Weight of at least 50 kg with a body-mass index \<=18.0 and \<=30.0 kg/m².
- Written informed consent obtained from the participant prior to performance of any study specific procedure, and which includes agreement to...
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of study...
- Participants who are healthy as established by medical evaluation including medical history, physical examination, cardiac monitoring, and clinical...
You likely can't join if
- History or presence/significant history of or current cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, immunological...
- Any condition where the administration of MDZ could be contraindicated, including but not limited to, hypersensitivity (MDZ, any of its excipients...
- History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix...
- History of any reaction or hypersensitivity likely to be exacerbated by any component (formulation, capsule, or excipients) of the study...
- Acute or chronic clinically significant pulmonary, endocrinological, cardiovascular, muscular, neurological, hepatic, or renal functional...
- Participants should have baseline clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the...
See the full eligibility criteria
Who can join
- Aged 18 to 55 years (inclusive), at the time of signing the informed consent form (ICF).
- Weight of at least 50 kg with a body-mass index \<=18.0 and \<=30.0 kg/m².
- Written informed consent obtained from the participant prior to performance of any study specific procedure, and which includes agreement to compliance, with the requirements and restrictions listed in the ICF and in...
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of study assessments, return for follow-up visits).
- Participants who are healthy as established by medical evaluation including medical history, physical examination, cardiac monitoring, and clinical laboratory assessment before entering into the study. Contraception:
- Male participants are eligible to participate.
- A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- Is a participant of non-childbearing potential (PONCBP). OR
- Is a POCBP and using a contraceptive method that is highly effective, with a failure rate of \<1%, for 30 days prior to and during the study intervention period and for at least 7 days after the last dose of GSK3772701...
- A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening and within 24 hours before the first dose of study intervention.
- A blood sample for simultaneous follicle-stimulating hormone (FSH) may be collected, and estradiol levels may be included at investigator's discretion to confirm non-reproductive potential when menopausal status is...
What rules you out
- History or presence/significant history of or current cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, immunological, dermatological, endocrine, hematologic, neurological, or psychiatric...
- Any condition where the administration of MDZ could be contraindicated, including but not limited to, hypersensitivity (MDZ, any of its excipients, or to any benzodiazepines), sleep apnea, glaucoma (narrow-angle...
- History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which is considered cured with minimal risk of...
- History of any reaction or hypersensitivity likely to be exacerbated by any component (formulation, capsule, or excipients) of the study intervention(s) (including hypromellose [hydroxypropyl methylcellulose] for...
- Acute or chronic clinically significant pulmonary, endocrinological, cardiovascular, muscular, neurological, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Participants should have baseline clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the investigator. A participant with a clinical abnormality or laboratory...
- Participants with supine blood pressure (BP) \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic).
- Estimated glomerular filtration rate (eGFR) of \<80 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021).
- The participant must agree to and adhere to the concomitant therapy (including non-drug therapies) restrictions from the Screening Visit through to the end of the study.
- Any other clinical condition that, in the opinion of the investigator, might pose an additional risk to the participant due to participation in the study or would make adhering to study procedures for the duration of...
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Past or intended use of over-the-counter or prescription medication (including herbal medications, vitamins and supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer), or 5 times the half-life...
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) or investigational drugs or non-registered product (drug, vaccine, or medical device) within 3 months or 5 times the half-life...
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current or prior enrolment in this or any other clinical study involving an investigational study intervention, or any other type of medical research, within the last 30 days or 5 half-lives, whichever is longer, prior...
- Positive drug/alcohol screen, including tetrahydrocannabinol at Screening or Admission.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months prior to Screening.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular alcohol consumption within 6 months prior to the clinical study defined as: An average weekly alcohol intake of 14 units for males or 7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint...
- Regular use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape".
- Participants who have lost or donated over 500 mL of blood within 90 days prior to enrollment or intend to donate blood or blood products during the study.
- Participants who have donated plasma within 7 days prior to enrollment.
- Any study personnel or their immediate dependents, family, or household members.
- Regular use of known drugs of abuse, including tetrahydrocannabinol.
- The following liver safety criteria are exclusionary:
- Alanine aminotransferase (ALT) \>1.5 × the upper limit of normal (ULN).
- Total bilirubin \>1.5 × ULN. Participants with Gilbert's syndrome can be included with total bilirubin \>1.5 × ULN if direct bilirubin is \<=1.5 × ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at Screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test results at Screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C RNA test results at Screening or within 3 months prior to first dose of study intervention.
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec.
- The participant has congenital long QT syndrome or known prolongation of the QTc interval.
- The participant has a family history of QT prolongation or sudden death.
- The participant has any current or previous history of episodes of symptomatic bradycardia or bradyarrhythmia.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.