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NCT03880825 · ClinicalTrials.gov registry record · Phase 1

Drug Interaction Study of Levoketoconazole and Metformin

A Phase 1 study, sponsored by Cortendo AB.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT03880825: Completed Phase 1 study, sponsored by Cortendo AB.

NCT03880825 is a Phase 1 study that has completed, run by Cortendo AB. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03880825, a Phase 1 study, has completed, sponsored by Cortendo AB.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

Primary Outcome

Maximum observed plasma concentration (Cmax) of metformin with and without concomitant administration of levoketoconazole.

Interventions

  • DRUG Metformin 500 mg Oral Tablet
  • DRUG Levoketoconazole 150 - 600 mg (BID)

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2019-03-28
Est. Completion 2019-05-03
Phase Phase 1
Cortendo AB

6 total trials

What the finished NCT03880825 record still lists

NCT03880825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Metformin 500 mg Oral Tablet is the first listed.

NCT03880825 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03880825 about?

NCT03880825 is a clinical study titled "Drug Interaction Study of Levoketoconazole and Metformin". This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

What is the current status of trial NCT03880825?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2019-03-28. Estimated completion is 2019-05-03.

What interventions are being tested in trial NCT03880825?

The interventions under investigation include: Metformin 500 mg Oral Tablet (DRUG), Levoketoconazole 150 - 600 mg (BID) (DRUG).

Who is sponsoring clinical trial NCT03880825?

This trial is sponsored by Cortendo AB, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03880825's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 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 NCT03880825, the US trial registry maintained by the National Library of Medicine. NCT03880825 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.