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

NCT06523595 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-993-006
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

VX-993 and Metformin

EXPERIMENTAL

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; Drug: Metformin

Interventions

VX-993 DRUG

Suspension for Oral Administration.

VX-993 and Metformin

Metformin DRUG

Tablets for Oral Administration.

VX-993 and Metformin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Metformin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: July 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)