Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a single-center, open-label, randomized, two-period, crossover study in approximately 14 healthy subjects. The goals of this study are as follows:
To assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteers.
To evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine.
To explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dexpramipexole single dose & 12 Doses Cimetidine 300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose) |
Drug: Cimetidine plus Dexpramipexole
Multiple Oral Doses
|
| Experimental: Dexpramipexole single Dose 300 mg Dexpramipexole Oral Dose |
Drug: Dexpramipexole
Single Oral Dose
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Overland Park | Kansas | United States |
Sponsors and Collaborators
- Knopp Biosciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 223HV104