CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Cladribine +1 moredrug
Likely dose
Cladribine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00938366
NCT00938366Phase 1Completed
CompareCT.gov

An Open-label, Cross Over Study, to Assess the Interactions of Pantoprazole (Proton Pump Inhibitor) With Oral Cladribine Administered in Subjects With Multiple Sclerosis

Merck KGaA, Darmstadt, Germany·interventional·Posted Jul 13, 2009·Updated Apr 14, 2016

In Brief

A Phase 1 clinical trial evaluating Cladribine and Pantoprazole for Multiple Sclerosis. Completed, enrolled 18 participants.

Detailed Summary

The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic profile of cladribine, especially in terms of extent of absorption of cladribine since pH-modifying drug may potentially affect the stability of cladribine and thereby its bioavailability

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
Countries--
CollaboratorsMerck Serono S.A., Geneva

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2009
Enrollment StartJan 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.0 years ago

Interventions

Cladribinedrug

Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days.

Pantoprazoledrug

Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period.