Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects

Akros Pharma Inc.70 enrolled

Overview

The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

JTK-853 or PlaceboDRUG

Tablets, single dose, fasted, fed or high-fat fed condition

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Body mass index (BMI) of 18-30 kg/m2 (inclusive) 2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit Exclusion Criteria: 1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death 2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing

Locations (1)

PPD, Phase I Clinic

Austin, Texas, United States

Outcomes

Primary Outcomes

Number of subjects with adverse events

Time frame: 1 week

Maximum concentration (Cmax) of JTK-853 and metabolite M2

Time frame: 1 week

Time to reach peak or maximum concentration following drug administration (tmax) for JTK-853 and metabolite M2

Time frame: 1 week

Area under the concentration-time curve from the time of dosing to the last quantifiable time point (AUClast) for JTK-853 and metabolite M2

Time frame: 1 week

Area under the concentration-time curve from the time of dosing to infinity (AUCinf) for JTK-853 and metabolite M2

Time frame: 1 week

Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2

Time frame: 1 week

Data from ClinicalTrials.gov

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