A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548

NCT05455502 | Completed Phase 1 FDA Drug

• 1 other identifier: VX21-548-011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability and food effect of a new tablet formulation of VX-548 in healthy adult participants.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of VX-548

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

• Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

• Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

Secondary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

• Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548 Metabolite

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

• Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 Metabolite

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose

• Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 up to Day 40

Study Arms (6)

Sequence 1

EXPERIMENTAL

Participants will receive VX-548 reference tablet (TF1) under fasted condition in dosing period 1, then VX-548 test tablet (TF2) under fasted condition in dosing period 2, and finally VX-548 test tablet (TF2) under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Drug: VX-548

Sequence 2

EXPERIMENTAL

Participants will receive VX-548 TF1 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Drug: VX-548

Sequence 3

EXPERIMENTAL

Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Drug: VX-548

Sequence 4

EXPERIMENTAL

Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Drug: VX-548

Sequence 5

EXPERIMENTAL

Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Drug: VX-548

Sequence 6

EXPERIMENTAL

Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF2 under fasted condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods.

Drug: VX-548

Interventions

VX-548 DRUG

Tablet for oral administration.

Also known as: Suzetrigine

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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 meter square (Kg/m\^2)
• A total body weight greater than (\>)50 kg

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
• Female participants of childbearing potential
• Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
• History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease

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

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: July 13, 2022
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)