Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects

Jeil Pharmaceutical Co., Ltd.80 enrolled

Overview

Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

JP-2266DRUG

* Single Ascending Dose: Single administration on Day 1 * Food effect cohort: Single administration on Day 1 of each period * Multiple Ascending Dose: Repeated administrations from D1 to D15

JP-2266 PlaceboDRUG

* Single Ascending Dose: Single administration on Day 1 * Food effect cohort: Single administration on Day 1 of each period * Multiple Ascending Dose: Repeated administrations from D1 to D15

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male Caucasian subject aged 18 to 50 years inclusive * Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening * Signing a written informed consent prior to selection; Exclusion Criteria: * Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;

Locations (1)

OPTIMED clinical research

Gières, France

RECRUITING

Outcomes

Primary Outcomes

The evaluation of the number of adverse events and the number and percentage of subjects

Single Ascending Dose

Time frame: up to Day 10

Assessment of PK parameter: Maximum plasma concentration (Cmax)

Food effect cohort

Time frame: up to 72hours of each period

The evaluation of the number of adverse events and the number and percentage of subjects

Multiple Ascending Dose

Time frame: up to Day 19

Central Contacts

Yves DONAZZOLO, MD, MSc,

CONTACT

33-438-372-747 YvesDonazzolo@eurofins.com

Data from ClinicalTrials.gov

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