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

Conditions

• Malaria, Falciparum

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Midazolam (MDZ) — DRUG
  Participants receive MDZ orally.
• GSK3772701 — DRUG
  Participants receive GSK3772701 orally.

Study Details

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.

Key Dates

First listed

Jun 26, 2026

Start date

Jun 26, 2026

Status verified

Jul 2026

Primary completion

Aug 24, 2026

Completion

Aug 24, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Study participants
  Healthy participants receive Midazolam (MDZ) on days 1, 3, 6 and 10, and GSK3772701 on days 3, 4 and 5.

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 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (1)

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