Evaluation of the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adults
Phase 1
Recruiting
- Conditions
- Pain
- Registration Number
- NCT06523595
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Key Inclusion Criteria:<br><br> - Body mass index (BMI) of 18.0 to 32.0 Kilogram per square meter (kg/m^2)<br><br> - A total body weight of more than (>) 50 Kg<br><br> - Nonsmoker or ex-smoker for at least 3 months before the first study drug dose<br><br>Key Exclusion Criteria:<br><br> - History of febrile illness or other acute illness that has not fully resolved within<br> 14 days before the first dose of study drug<br><br> - Any condition possibly affecting drug absorption, distribution, metabolism, or<br> excretion<br><br>Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993;Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993;Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Metformin in Absence and Presence of VX-993
- Secondary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Renal Clearance (CLr) of Metformin in the Presence and Absence of VX-993;Metformin Fraction Excreted Unchanged (fe) in Urine in the Presence and Absence of VX-993