GSK Investigational Site
Cambridge, CB2 0GG, United Kingdom
NCT Number: NCT05760261
The objective of this study is to determine the magnitude and clinical relevance of a potential drug-drug interaction of GSK3882347 with midazolam (MDZ) in healthy participants. This study assesses the effect of GSK3882347 as an inducer of Cytochrome P450 3A4 (CYP3A4) using MDZ, a sensitive substrate of hepatic and intestinal CYP3A4. The study will investigate MDZ pharmacokinetic (PK) effect in two dosing periods:
Period 1: A single dose of MDZ Period 2: 14-days of once daily repeat dosing of GSK3882347 followed by single dose of MDZ co-administered with GSK3882347 on Day 15 (14-days has been selected as this duration is required in order to maximize any potential CYP3A4 enzyme induction).
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Cambridge, CB2 0GG, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Plus, either:
OR
Exclusion criteria
Midazolam will be administered.
GSK3882347 will be administered.
Time frame: Up to 24 hours
Time frame: Up to 24 hours
Time frame: Up to 24 hours
Time frame: Up to 24 hours
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to 24 hours
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 2
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 2
Time frame: Up to Day 15
GlaxoSmithKline
Industry
A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 65 Years to Investigate the CYP3A4 Induction Potential of GSK3882347
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07627412
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Nanjing, Jiangsu, China
View Trial DetailsNCT06801405
Acute Kidney Injury, Antibiotic Prophylaxis
Jales, São Paulo, Brazil
View Trial DetailsNCT05319561
Common Infections, Female Urogenital Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT07438184
Chronic Prostatitis (CP), Female Urogenital Diseases
Salamanca, Spain
View Trial Details