Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects

Phase 1TerminatedNCT01473069

Akros Pharma Inc.41 enrolled

Overview

The purpose of this study was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

JTK-853, ketoconazoleDRUG

JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15

JTK-853 or PlaceboDRUG

JTK-853 Tablets or Placebo, twice a day for 14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2 2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit 3. Female subjects must be either surgically sterile or postmenopausal 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 four weeks prior to Day -1

Locations (1)

PPD Phase I Clinic

Austin, Texas, United States

Outcomes

Primary Outcomes

Number of subjects with adverse events

Time frame: 3 weeks

Secondary Outcomes

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

Time frame: 3 weeks

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

Time frame: 3 weeks

Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2

Time frame: 3 weeks

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: 3 weeks

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

Time frame: 3 weeks

Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration

Time frame: 3 weeks

Data from ClinicalTrials.gov

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