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