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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: VX-548

Study type: Interventional

Funder types: Industry

Identifiers

NCT05455502

VX21-548-011

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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

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
• 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: VX-548

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: VX-548

Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: VX-548

Sequence 4

Experimental group

Description:

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.

Treatment:

Drug: VX-548

Sequence 5

Experimental group

Description:

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.

Treatment:

Drug: VX-548

Sequence 6

Experimental group

Description:

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.

Treatment:

Drug: VX-548