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NCT01358968 · ClinicalTrials.gov registry record · Phase 1

A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine

A Phase 1 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01358968: Completed Phase 1 study, sponsored by Eli Lilly and Company.

NCT01358968 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01358968, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effect LY2603618 on a protein \[enzyme cytochrome P (CYP) 2D6\] which is involved in the metabolic pathway of Desipramine in participants with cancer. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study. The study involves two single doses of 50 milligrams (mg), 1 tablet by mouth, on Day 1 of Period 1 and 2. In Period 1 Desipramine will be administered alone. In Period 2 Desipramine will be administered in combination with LY2603618. LY2603618 will be administered as a 275mg intravenous (IV) infusion over 1 hour (hr). Desipramine will be administered at the end of the LY2603618 infusion. Information about any side effects that may occur will also be collected.

Interventions

  • DRUG Pemetrexed
  • DRUG Gemcitabine
  • DRUG Desipramine
  • DRUG LY2603618

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-06
Est. Completion 2012-12
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT01358968 record still lists

NCT01358968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

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

NCT01358968 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01358968 about?

NCT01358968 is a clinical study titled "A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine". The purpose of this study is to assess the effect LY2603618 on a protein \[enzyme cytochrome P (CYP) 2D6\] which is involved in the metabolic pathway of Desipramine in participants with cancer. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study...

What is the current status of trial NCT01358968?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01358968?

The interventions under investigation include: Pemetrexed (DRUG), Gemcitabine (DRUG), Desipramine (DRUG), LY2603618 (DRUG).

Who is sponsoring clinical trial NCT01358968?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01358968's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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 NCT01358968, the US trial registry maintained by the National Library of Medicine. NCT01358968 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.