Last updated: 06/19/2026 10:40:08

Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years

GSK study ID
300294
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1, Open-Label study in Healthy Participants aged 18 to 55 years to Investigate the CYP3A4 Interaction Potential of GSK3772701
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Maximum observed concentration (Cmax) of MDZ

Timeframe: 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

Timeframe: 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

Timeframe: 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:

Cmax of 1-hydroxymidazolam (OH-MDZ)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: From Day 1 to Day 12

Incidence of serious adverse events (SAEs) overall, by severity and relationship to GSK3772701

Timeframe: From Day -30 to Day 12

Interventions:
Drug: Midazolam (MDZ)
Drug: GSK3772701
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
2026-27-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Malaria, Falciparum
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2026 to August 2026
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
  • 1. Aged 18 to 55 years (inclusive), at the time of signing the informed consent form (ICF).
  • 2. Weight of at least 50 kg with a body-mass index <=18.0 and <=30.0 kg/m².
  • 1. 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.
  • 2. 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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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