Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects

Knopp Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Dexpramipexole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01607034

223HV106

Details and patient eligibility

About

To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in intact tablet form in the fasted and fed states in healthy volunteers.

Full description

The effect of food on dexpramipexole bioavailability following administration of the proposed commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg twice daily) has not been studied. Therefore, this study has been designed to evaluate the effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following administration of a single 150 mg dose in healthy volunteers, consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.

Additionally, patients with ALS can have difficulty swallowing tablets, necessitating alternative methods of administration for the drug. Therefore, this study has also been designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in soft food (applesauce).

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• History of malignant disease, including solid tumors and hematologic malignancies.
• History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
• Surgery within 90 days prior to check in.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Sequence 1 - tablet-fast

Experimental group

Description:

150 mg Dexpramipexole (intact tablet) single dose under fasted condition

Treatment:

Drug: Dexpramipexole

Sequence 2 - tablet-fed

Experimental group

Description:

150 mg Dexpramipexole (intact tablet) single dose under fed condition

Treatment:

Drug: Dexpramipexole

Sequence 3 - water-fast

Experimental group

Description:

150 mg Dexpramipexole single dose dispersed in water under fasted condition

Treatment:

Drug: Dexpramipexole

Sequence 4 - apple-fast

Experimental group

Description:

150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition

Treatment:

Drug: Dexpramipexole