A Phase 1, Open-label Study Evaluating the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- VX-993
- Conditions
- Pain
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic drug-drug interactions, safety, and tolerability of co-administration of VX-993 and metformin in healthy participants.
Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) of 18.0 to 32.0 Kilogram per square meter (kg/m\^2)
- •A total body weight of more than (\>) 50 Kg
- •Nonsmoker or ex-smoker for at least 3 months before the first study drug dose
Exclusion Criteria
- •History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- •Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
VX-993 and Metformin
Metformin will be administered to participants as a single oral dose on Day 1 and then co-administered with VX-993 on Day 10. VX-993 dose will be administered every 12 hours (q12h) from Day 5 through Day 14.
Intervention: VX-993
VX-993 and Metformin
Metformin will be administered to participants as a single oral dose on Day 1 and then co-administered with VX-993 on Day 10. VX-993 dose will be administered every 12 hours (q12h) from Day 5 through Day 14.
Intervention: Metformin
Outcomes
Primary Outcomes
Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993
Time Frame: From Day 1 up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993
Time Frame: From Day 1 up to Day 14
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
Time Frame: From Day 1 up to Day 14
Secondary Outcomes
- Renal Clearance (CLr) of Metformin in the Presence and Absence of VX-993(From Day 1 up to Day 14)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 29)
- Metformin Fraction Excreted Unchanged (fe) in Urine in the Presence and Absence of VX-993(From Day 1 up to Day 14)