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

A Phase 1, Open-label Study Evaluating the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: VX-993; Drug: Metformin

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON Salt Lake City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: VX-993; Suspension for Oral Administration.; Drug: Metformin; Tablets for Oral Administration.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: VX24-993-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No