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Recruiting NCT07670377

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

Conditions: Malaria, Falciparum

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 20
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Miami Florida

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 co-administration with CYP3A4 substrates.

Eligibility Criteria

Inclusion Criteria: 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 \1.5 × ULN if direct bilirubin is \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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07670377). StuddyBuddy aggregates publicly available trial information.