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NCT01768663 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

A Phase 1 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target

NCT01768663 is a Phase 1 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 80 participants.

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The verdict

NCT01768663, a Phase 1 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target

Study Summary

The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.

Interventions

  • DRUG Rifampin
  • DRUG Itraconazole
  • DRUG Ciprofloxacin
  • DRUG Ivacaftor
  • DRUG Lumacaftor

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2013-01
Phase Phase 1

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT01768663

The ClinicalTrials.gov registry entry for NCT01768663 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Rifampin is the first listed.

NCT01768663 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01768663 about?

NCT01768663 is a clinical study titled "A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects". The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.

What is the current status of trial NCT01768663?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2013-01.

What interventions are being tested in trial NCT01768663?

The interventions under investigation include: Rifampin (DRUG), Itraconazole (DRUG), Ciprofloxacin (DRUG), Ivacaftor (DRUG), Lumacaftor (DRUG).

Who is sponsoring clinical trial NCT01768663?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.