Pain
Conditions
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.).
Interventions
DRUGVX-993
Suspension for Oral Administration.
DRUGMetformin
Tablets for Oral Administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key 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 Key
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993 | From Day 1 up to Day 14 |
| Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993 | 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 | From Day 1 up to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Renal Clearance (CLr) of Metformin in the Presence and Absence of VX-993 | From Day 1 up to Day 14 |
| Metformin Fraction Excreted Unchanged (fe) in Urine in the Presence and Absence of VX-993 | From Day 1 up to Day 14 |
Countries
United States
Outcome results
None listed