The Food Effect on PK Characteristics and Safety Profiles of PA-111

Addpharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Mixed Dyslipidemia

Treatments: Drug: PA-111

Study type: Interventional

Funder types: Industry

Identifiers

NCT06976489

PA-111FE

Details and patient eligibility

About

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

Full description

The purpose of this study is to compare and evaluate the effect of food on the safety and pharmacokinetic profiles of PA-111 in healthy adult subjects.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ 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
• The Age equal to or greater than 19 in healthy volunteers 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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40 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: Fasted, Period 2: Fed

Treatment:

Drug: PA-111

Sequence B

Experimental group

Description:

Period 1: Fed, Period 2: Fasted

Treatment:

Drug: PA-111