Drug-Interaction Study of GSK3772701
This study is looking at how a drug called GSK3772701 interacts with another drug, midazolam (MDZ), in healthy men and women aged 18 to 55. Midazolam is used to understand how the body processes drugs through a specific enzyme (CYP3A4). Researchers want to see if GSK3772701 changes how midazolam is handled by the body. This information will help doctors know how to safely give GSK3772701 with other medications. The study will measure the levels of midazolam in your blood at different times after you take it. The goal is to enroll 20 participants.
- Study design
- This is an interventional study planning to enroll 20 healthy male and female participants. It is designed to understand drug interactions.
- What's involved
- You would receive midazolam and GSK3772701 orally. Blood samples would be taken at specific times on days 1, 3, 6, and 10 to measure drug levels.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood samples are collected up to 24 hours post-dose on specific days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07670377
Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years
Recruiting
PHASE1Ages 18–55InterventionalBasic scienceGlaxoSmithKline
~20 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Midazolam (MDZ)GSK3772701
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum observed concentration (Cmax) of MDZ
Measured over 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
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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: 6. Is a participant of non-childbearing potential (PONCBP). OR 7. 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. 8. 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. 9. 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.
Exclusion
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. 26. QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 msec. 27. The participant has congenital long QT syndrome or known prolongation of the QTc interval. 28. The participant has a family history of QT prolongation or sudden death. 29. The participant has any current or previous history of episodes of symptomatic bradycardia or bradyarrhythmia.
What this trial measures
- Maximum observed concentration (Cmax) of MDZAt 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 MDZAt 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 MDZAt 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