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

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JTK-853 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475981

AK853-U-09-001

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 11 patient groups, including a placebo group

Dose 1 JTK-853 (fasted condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 2 JTK-853 (fasted condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 3 JTK-853 (fasted condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 2 JTK-853 (fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 3 JTK-853 (fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 4 JTK-853 (fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 5 JTK-853 (fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 6 JTK-853 (fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 7 JTK-853 (fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 5 JTK-853 (high-fat fed condition)

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: JTK-853 or Placebo