Food Effect Study of VHX-896 in Healthy Volunteers

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: VHX-896

Study type: Interventional

Funder types: Industry

Identifiers

NCT06803290

VP-VHX-896-1102

Details and patient eligibility

About

A single center, two-period, randomized study to evaluate the food effect of VHX-896 tablets in healthy volunteers

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female participants between 18 to 55 years (inclusive).
• Have a Body Mass Index (BMI) of > 18.0 and < 30.0 kg/m2; (BMI = weight (kg)/ [height (m)]2).
• Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations.
• No clinically significant medical, psychiatric or sleep disorders.

Exclusion criteria

• Participants with history of drug or alcohol abuse in last 12 months.
• Participants who suffered from significant physical illness in the 4-week period preceding baseline.
• Pregnant or nursing (lactating) women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sequence A: fed then fasted

Experimental group

Treatment:

Drug: VHX-896

Sequence B: fasted then fed

Experimental group

Treatment:

Drug: VHX-896