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NCT01473069 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Akros Pharma.

Terminated
Registry status
Phase 1
Development phase
41
Enrollment target

NCT01473069: Clinical Trial Phase 1 study, sponsored by Akros Pharma.

NCT01473069 is a Phase 1 study that was terminated before completion, run by Akros Pharma. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01473069, a Phase 1 study, was terminated before completion, sponsored by Akros Pharma.

TERMINATED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

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).

Interventions

  • DRUG JTK-853 or Placebo
  • DRUG JTK-853, ketoconazole

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2010-03
Est. Completion 2010-07
Phase Phase 1
Akros Pharma

18 total trials

Why NCT01473069 stopped before completion

NCT01473069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which JTK-853 or Placebo is the first listed.

NCT01473069 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01473069 about?

NCT01473069 is a clinical study titled "Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects". 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 ...

What is the current status of trial NCT01473069?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2010-03. Estimated completion is 2010-07.

What interventions are being tested in trial NCT01473069?

The interventions under investigation include: JTK-853 or Placebo (DRUG), JTK-853, ketoconazole (DRUG).

Who is sponsoring clinical trial NCT01473069?

This trial is sponsored by Akros Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01473069's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01473069, the US trial registry maintained by the National Library of Medicine. NCT01473069 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.