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NCT01054118 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin

A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT01054118: Completed Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT01054118 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01054118, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male volunteers.

Interventions

  • DRUG Placebo
  • DRUG Sitagliptin 100 mg
  • DRUG JNJ-38431055
  • DRUG JNJ-38431055 + Sitagliptin 100 mg

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2009-12
Est. Completion 2010-02
Phase Phase 1

What the finished NCT01054118 record still lists

NCT01054118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01054118 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01054118 about?

NCT01054118 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin". This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese...

What is the current status of trial NCT01054118?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2009-12. Estimated completion is 2010-02.

What interventions are being tested in trial NCT01054118?

The interventions under investigation include: Placebo (DRUG), Sitagliptin 100 mg (DRUG), JNJ-38431055 (DRUG), JNJ-38431055 + Sitagliptin 100 mg (DRUG).

Who is sponsoring clinical trial NCT01054118?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01054118's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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 NCT01054118, the US trial registry maintained by the National Library of Medicine. NCT01054118 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.