Evaluation of the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adults

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: VX-993; Drug: Metformin

• Registration Number: NCT06523595
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.).

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Study Start: 2024-07-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VX-993 and Metformin	VX-993	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.
VX-993 and Metformin	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.

Primary Outcome Measures

Name	Time	Method
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
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 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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

ICON Salt Lake City; 🇺🇸 Salt Lake City, Utah, United States