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NCT01759576 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function

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

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT01759576: Completed Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT01759576 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01759576, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying degrees of kidney impairment (including volunteers with end-stage renal disease requiring hemodialysis).

Primary Outcome

Plasma concentrations of canagliflozin (JNJ-28431754) following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug) in varying degrees of kidney function.

Interventions

  • DRUG Canagliflozin (JNJ-28431754)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2008-03
Est. Completion 2008-11
Phase Phase 1

What the finished NCT01759576 record still lists

NCT01759576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 1 intervention - of which Canagliflozin (JNJ-28431754) is the first listed.

NCT01759576 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01759576 about?

NCT01759576 is a clinical study titled "A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function". The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volun...

What is the current status of trial NCT01759576?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2008-03. Estimated completion is 2008-11.

What interventions are being tested in trial NCT01759576?

The interventions under investigation include: Canagliflozin (JNJ-28431754) (DRUG).

Who is sponsoring clinical trial NCT01759576?

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 NCT01759576's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 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 NCT01759576, the US trial registry maintained by the National Library of Medicine. NCT01759576 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.