A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 55 Years to Investigate the CYP3A4 Interaction Potential of GSK3772701
GlaxoSmithKline
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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 \<=18.0 and \<=30.0 kg/m². 3. Written informed consent obtained from the participant prior to performance of any study specific procedure, and which includes agreement to compliance, with the requirements and restrictions listed in the ICF and in this protocol. 4. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of study assessments, return for follow-…
Interventions
- DrugMidazolam (MDZ)
Participants receive MDZ orally.
- DrugGSK3772701
Participants receive GSK3772701 orally.
Location
- GSK Investigational SiteMiami, Florida