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

Akros Pharma

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: JTK-853, ketoconazole; Drug: JTK-853 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473069

AK853-U-10-003

Details and patient eligibility

About

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).

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

41 participants in 5 patient groups, including a placebo group

Dose 1 JTK-853, 400 mg ketoconazole

Experimental group

Treatment:

Drug: JTK-853, ketoconazole

Dose 2 JTK-853

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 3 JTK-853

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Dose 4 JTK-853

Experimental group

Treatment:

Drug: JTK-853 or Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: JTK-853 or Placebo