Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Completed · Phase 1

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT01536249

Run by

Knopp Biosciences

People needed

14

Starts

2012-03-01

Expected to finish

2012-04-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects who, in the opinion of the Investigator, are healthy as determined by medical history, physical examination, and 12 lead ECG
• Adult males/females aged 18 to 55 years inclusive
• Male and female subjects of childbearing potential must practice effective contraception during the study and up to 90 days after their last dose.

You may not qualify if…

• History of malignant disease, including solid tumors and hematologic malignancies.
• History of clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
• Treatment with prescription medication and/or over-the-counter products and herbal-containing and/or alternative health preparations and procedures.
• Surgery within 90 days prior to check-in.

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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