A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SSP-004184SS; Drug: SSP-004184AQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT01905540

SPD602-111

Details and patient eligibility

About

This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-65 years
• Must be considered "healthy".
• Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Exclusion criteria

• Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
• Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.
• Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
• Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
• History of alcohol or other substance abuse within the last year.
• A positive screen for alcohol or drugs of abuse at the Screening Visit.
• Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
• Twelve-lead ECG demonstrating QTc >450msec at screening.
• Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
• Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
• A positive HIV antibody screen, HBsAg, or HCV antibody screen.
• Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

SSP-004184AQ (single dose)

Experimental group

Description:

40 mg/kg (oral capsule form) given once on Day 1

Treatment:

Drug: SSP-004184AQ

SSP-004184SS (single dose)

Experimental group

Description:

21.8 mg/kg (oral capsule form) given once on Day 1

Treatment:

Drug: SSP-004184SS

SSP-004184AQ (2 doses)

Experimental group

Description:

40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Treatment:

Drug: SSP-004184AQ

SSP-004184SS (2 doses)

Experimental group

Description:

21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Treatment:

Drug: SSP-004184SS