Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

NCT01536249 | Completed Phase 1

• 1 other identifier: 223HV104
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Determination of the effect of cimetidine on the PK of dexpramipexole parameters including: AUC: Area under the plasma-concentration time curve over a specified time period; Cmax: Maximum observed plasma concentration and CLr: renal clearance

  pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours after dexpramipexole administration in each dosing period.

Secondary Outcomes (1)

• PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine

  pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours after dexpramipexole administration in each dosing period.

Study Arms (2)

Dexpramipexole single dose & 12 Doses Cimetidine

EXPERIMENTAL

300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)

Drug: Cimetidine plus Dexpramipexole

Dexpramipexole single Dose

EXPERIMENTAL

300 mg Dexpramipexole Oral Dose

Drug: Dexpramipexole

Interventions

Dexpramipexole DRUG

Single Oral Dose

Dexpramipexole single Dose

Cimetidine plus Dexpramipexole DRUG

Multiple Oral Doses

Dexpramipexole single dose & 12 Doses Cimetidine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Knopp Biosciences: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Dexpramipexole; Cimetidine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Guanidines; Amidines; Organic Chemicals; Imidazoles

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

US (1)