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

NCT01475981 | Completed Phase 1

• 1 other identifier: AK853-U-09-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

JTK-853; single dose

Outcome Measures

Primary Outcomes (6)

• Number of subjects with adverse events

  1 week

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

  1 week

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

  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

  1 week

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

  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

  1 week

Study Arms (11)

Dose 1 JTK-853 (fasted condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 2 JTK-853 (fasted condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 3 JTK-853 (fasted condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 2 JTK-853 (fed condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 3 JTK-853 (fed condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 4 JTK-853 (fed condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 5 JTK-853 (fed condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 6 JTK-853 (fed condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

Dose 7 JTK-853 (fed condition)

EXPERIMENTAL

Drug: JTK-853 or Placebo

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

EXPERIMENTAL

Drug: JTK-853 or Placebo

Placebo

PLACEBO COMPARATOR

Drug: JTK-853 or Placebo

Interventions

JTK-853 or Placebo DRUG

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

Dose 1 JTK-853 (fasted condition); Dose 2 JTK-853 (fasted condition); Dose 2 JTK-853 (fed condition); Dose 3 JTK-853 (fasted condition); Dose 3 JTK-853 (fed condition); Dose 4 JTK-853 (fed condition); Dose 5 JTK-853 (fed condition); Dose 5 JTK-853 (high-fat fed condition); Dose 6 JTK-853 (fed condition); Dose 7 JTK-853 (fed condition); Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of 18-30 kg/m2 (inclusive)
• Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit

You may not qualify if:

• History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
• Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen), within 4 weeks prior to the Day before dosing

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (1)

PPD, Phase I Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

JTK-853

Study Officials

• Shoji Hoshino, D.V.M

  Akros Pharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 22, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

US (1)