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NCT01536249 · ClinicalTrials.gov registry record · Phase 1

Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

A Phase 1 study, sponsored by Knopp Biosciences.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01536249: Completed Phase 1 study, sponsored by Knopp Biosciences.

NCT01536249 is a Phase 1 study that has completed, run by Knopp Biosciences. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01536249, a Phase 1 study, has completed, sponsored by Knopp Biosciences.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

This study will assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteer and evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine. Additionally, this study will explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.

Interventions

  • DRUG Dexpramipexole
  • DRUG Cimetidine plus Dexpramipexole

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-03
Est. Completion 2012-04
Phase Phase 1
Knopp Biosciences

12 total trials

What the finished NCT01536249 record still lists

NCT01536249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Dexpramipexole is the first listed.

NCT01536249 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01536249 about?

NCT01536249 is a clinical study titled "Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)". This study will assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteer and evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine. Additionally, this study will explore the influence of genetic variation on the PK of ...

What is the current status of trial NCT01536249?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-03. Estimated completion is 2012-04.

What interventions are being tested in trial NCT01536249?

The interventions under investigation include: Dexpramipexole (DRUG), Cimetidine plus Dexpramipexole (DRUG).

Who is sponsoring clinical trial NCT01536249?

This trial is sponsored by Knopp Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01536249's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 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 NCT01536249, the US trial registry maintained by the National Library of Medicine. NCT01536249 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.