Malaria, FalciparumPhase 1NCT07670377
Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years
A Phase 1 study testing Midazolam (MDZ) and GSK3772701 in people with Malaria, Falciparum, run by GlaxoSmithKline at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Midazolam (MDZ) and GSK3772701
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to 24 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to 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 this protocol.
- 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:
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- 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 and at least 2 days after the last dose of MDZ.
- 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 uncertain according to the local laboratory reference range.
Who cannot join
- History or presence/significant history of or current cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, immunological, dermatological, endocrine, hematologic, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- 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 glaucoma, acute or open angle glaucoma, untreated), myasthenia gravis, respiratory insufficiency, impaired pulmonary function, or severe hepatic impairment.
- 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 recurrence. Participants under evaluation for possible malignancy are not eligible.
- 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 GSK3772701) or allergies to cherries (as per MDZ USPI).
- 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 parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the investigator considers that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.
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- 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 the study difficult.
- 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 (whichever is longer) prior to dosing.
- 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 (whichever is longer) prior to dosing.
- 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 to signing of the ICF.
- Participants who screen fail for the current study are not eligible for re-screening or enrollment.
- 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. (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 55 Years to Investigate the CYP3A4 Interaction Potential of GSK3772701
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.
- Conditions
- Malaria, Falciparum
- Being tested
- Midazolam (MDZ), GSK3772701
- Keywords
- GSK3772701, Pharmacokinetics, Midazolam, CYP3A4, Healthy participants, Open label
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam (MDZ)Drug
Participants receive MDZ orally.
GSK3772701Drug
Participants receive GSK3772701 orally.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | Healthy participants receive Midazolam (MDZ) on days 1, 3, 6 and 10, and GSK3772701 on days 3, 4 and 5. Receives: Drug: Midazolam (MDZ); Drug: GSK3772701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of MDZ
Measured: At 0 hours (h) (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Area under the concentration-time curve. from time 0 to the last measurable concentration [AUC(0-t)] of MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] of MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Secondary outcomes (16)
Cmax of 1-hydroxymidazolam (OH-MDZ)
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
AUC(0-t) of 1-OH-MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
AUC(0-inf) of 1-OH-MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Metabolite-to-parent ratios (1-OH-MDZ/MDZ) based on Cmax
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Metabolite-to-parent ratios (1-OH-MDZ/MDZ) based on AUC(0-t)
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Metabolite-to-parent ratios (1-OH-MDZ/MDZ) based on AUC(0-inf)
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Time to maximum observed concentration (Tmax) of MDZ and 1-OH-MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Terminal half-life (t1/2) of MDZ and 1-OH-MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Apparent oral plasma clearance (CL/F) of MDZ
Measured: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Cmax of GSK3772701
Measured: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
AUC(0-t) of GSK3772701
Measured: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of GSK3772701
Measured: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
Tmax of GSK3772701
Measured: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
Concentration at 24 hours post dose (C24h) of GSK3772701
Measured: At Day 4 pre-dose (24 hours post Day 3 dose), Day 5 pre-dose (24 hours post Day 4 dose) and Day 6 (24 hours post Day 5 dose)
Incidence of adverse events (AEs) overall, by severity and relationship to GSK3772701
An AE is defined as 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. The severity of AEs is determined by the investigator using the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading of Severity of Adult and Pediatric Adverse Events, corrected version 2.1. Grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. Higher grades indicate greater severity. The incidence rate describes the rate at which an event occurs.
Measured: From Day 1 to Day 12
Incidence of serious adverse events (SAEs) overall, by severity and relationship to GSK3772701
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participants offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigators judgement. The severity of SAEs is determined by the investigator using the DAIDs Table for Grading of Severity of Adult and Pediatric Adverse Events, corrected version 2.1. Grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. Higher grades indicate greater severity. The incidence rate describes the rate at which an event occurs.
Measured: From Day -30 to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start26 Jun 2026
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670377
- Sponsor's protocol ID
- 300294
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 55 Years to Investigate the CYP3A4 Interaction Potential of GSK3772701
- ClinicalTrials.gov ID
- NCT07670377
- Acronym / sponsor ID
- 300294
- Conditions
- Malaria, Falciparum
- Keywords
- GSK3772701, Pharmacokinetics, Midazolam, CYP3A4, Healthy participants, Open label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Drug: Midazolam (MDZ), Drug: GSK3772701Healthy participants receive Midazolam (MDZ) on days 1, 3, 6 and 10, and GSK3772701 on days 3, 4 and 5. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 this protocol.
- 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.
Key exclusion criteria (36 listed)
- History or presence/significant history of or current cardiovascular, respiratory, hepatic, renal, urological, gastrointestinal, immunological, dermatological, endocrine, hematologic, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- 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 glaucoma, acute or open angle glaucoma, untreated), myasthenia gravis, respiratory insufficiency, impaired pulmonary function, or severe hepatic impairment.
- 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 recurrence. Participants under evaluation for possible malignancy are not eligible.
- 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 GSK3772701) or allergies to cherries (as per MDZ USPI).
- Acute or chronic clinically significant pulmonary, endocrinological, cardiovascular, muscular, neurological, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam (MDZ)Participants receive MDZ orally. | Drug | Study participants |
| GSK3772701Participants receive GSK3772701 orally. | Drug | Study participants |
Primary outcome
Maximum observed concentration (Cmax) of MDZ
Time frame: At 0 hours (h) (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Area under the concentration-time curve. from time 0 to the last measurable concentration [AUC(0-t)] of MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] of MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
16 secondary outcomes
Cmax of 1-hydroxymidazolam (OH-MDZ)
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
AUC(0-t) of 1-OH-MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
AUC(0-inf) of 1-OH-MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Metabolite-to-parent ratios (1-OH-MDZ/MDZ) based on Cmax
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Metabolite-to-parent ratios (1-OH-MDZ/MDZ) based on AUC(0-t)
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Metabolite-to-parent ratios (1-OH-MDZ/MDZ) based on AUC(0-inf)
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Time to maximum observed concentration (Tmax) of MDZ and 1-OH-MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Terminal half-life (t1/2) of MDZ and 1-OH-MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Apparent oral plasma clearance (CL/F) of MDZ
Time frame: At 0h (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10
Cmax of GSK3772701
Time frame: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
AUC(0-t) of GSK3772701
Time frame: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of GSK3772701
Time frame: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
Tmax of GSK3772701
Time frame: At 0h (pre-dose) and at 0.5, 1, 2, 3, 4, 6, 12, 20 and 24 hours post-dose on days 3 and 5
Concentration at 24 hours post dose (C24h) of GSK3772701
Time frame: At Day 4 pre-dose (24 hours post Day 3 dose), Day 5 pre-dose (24 hours post Day 4 dose) and Day 6 (24 hours post Day 5 dose)
Incidence of adverse events (AEs) overall, by severity and relationship to GSK3772701
Time frame: From Day 1 to Day 12
Incidence of serious adverse events (SAEs) overall, by severity and relationship to GSK3772701
Time frame: From Day -30 to Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam (MDZ) and GSK3772701 in people with Malaria, Falciparum, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of MDZ (time frame: At 0 hours (h) (pre-dose) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose for each MDZ administration on days 1, 3, 6 and 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.