A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers

Addpharma

Status and phase: Invitation-only; Phase 1

Conditions: Mixed Dyslipidemia; Food Effect Study of AD-117

Treatments: Drug: AD-117

Study type: Interventional

Funder types: Industry

Identifiers

NCT07495514

AD-117FE

Details and patient eligibility

About

A Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics and Safety Profile of AD-117 in Healthy Adult Volunteers

Full description

An open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the food effect on the safety and the pharmacokinetics of AD-117 in healthy adult volunteers

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
• Healthy volunteers aged ≥19 and <65 years at the time of screening visit

Exclusion criteria

• Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: Fasted, Period 2: Fed

Treatment:

Drug: AD-117

Sequence B

Experimental group

Description:

Period 1: Fed, Period 2: Fasted

Treatment:

Drug: AD-117