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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: Completed Phase 1 study, sponsored by Vertex Pharmaceuticals Incorporated.

NCT01768663 is a Phase 1 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Vertex Pharmaceuticals Incorporated

191 total trials

What the finished NCT01768663 record still lists

NCT01768663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).

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

NCT01768663 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01768663's enrollment target sits among peer trials

80 672nd of 2000 higher than 1,305 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 NCT01768663, the US trial registry maintained by the National Library of Medicine. NCT01768663 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.