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

NCT01905540 | Completed Phase 1 Results

• 1 other identifier: SPD602-111
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose

  AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body

  Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

• Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose

  AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

  Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

• Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose

  Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated

  Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Secondary Outcomes (3)

• Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses

  Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

• Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses

  Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

• Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses

  Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Study Arms (4)

SSP-004184AQ (single dose)

EXPERIMENTAL

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

Drug: SSP-004184AQ

SSP-004184SS (single dose)

EXPERIMENTAL

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

Drug: SSP-004184SS

SSP-004184AQ (2 doses)

EXPERIMENTAL

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

Drug: SSP-004184AQ

SSP-004184SS (2 doses)

EXPERIMENTAL

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

Drug: SSP-004184SS

Interventions

SSP-004184AQ DRUG

Magnesium salt

Also known as: SPD602

SSP-004184AQ (2 doses); SSP-004184AQ (single dose)

SSP-004184SS DRUG

Disodium salt

Also known as: SPD602

SSP-004184SS (2 doses); SSP-004184SS (single dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: July 18, 2013
• First Posted: July 23, 2013
• Study Start: August 5, 2013
• Primary Completion: September 20, 2013
• Study Completion: September 20, 2013
• Last Updated: July 19, 2021
• Results First Posted: December 24, 2014

Record last verified: 2021-06

Locations

US (1)