Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)

NCT02065401 | Withdrawn Phase 1

• 1 other identifier: SPD602-112
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Curve (AUC) of Deferitazole

  AUC of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt

  Up to 120 hours post-dose

• Maximum Plasma Concentration (Cmax) of Deferitazole

  Cmax of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt

  Up to 120 hours post-dose

Secondary Outcomes (2)

• Taste of Deferitazole

  Immediately after dose and 5 minutes post-dose

• Bioequivalence of Deferitazole Disodium Salt Granule Formulation With Tablet Formulation

  Up to 120 hours post-dose

Study Arms (3)

Deferitazole (disodium salt, granule)

EXPERIMENTAL

Drug: Deferitazole (disodium salt, granule)

Deferitazole (disodium salt, tablet)

EXPERIMENTAL

Drug: Deferitazole (disodium salt, tablet)

Deferitazole (magnesium hydroxide salt)

EXPERIMENTAL

Drug: Deferitazole (magnesium hydroxide salt)

Interventions

Deferitazole (disodium salt, granule) DRUG

Single oral dose of 1500 mg administered on Day 1

Also known as: SPD602, SSP-004184, SSP-004184SS

Deferitazole (disodium salt, granule)

Deferitazole (disodium salt, tablet) DRUG

Single oral dose of 1500 mg administered on Day 1

Also known as: SPD602, SSP-004184, SSP-004184SS

Deferitazole (disodium salt, tablet)

Deferitazole (magnesium hydroxide salt) DRUG

Single oral dose of 2400 mg administered on Day 1

Also known as: SPD602, SSP-004184AQ, SSP-004184

Deferitazole (magnesium hydroxide salt)

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 inclusive at the time of consent.
• Must be considered "healthy".
• Serum ferritin, hemoglobin and erythrocyte indices (packed cell volume, mean corpuscular volume and mean corpuscular hemoglobin concentration) within normal range.
• Willingness to comply with any applicable contraceptive requirements of the protocol and is:
• Male, or
• Female of non-childbearing potential (defined as a female who is post-menopausal )
• Non-pregnant, non-lactating female
• Females must be at least 90 days post partum or nulliparous.
• Body weight equal to or greater than 60kg.
• Ability to swallow a dose of the investigational product.

You may not qualify if:

• Subject has a clinically significant history or a disorder detected during the medical interview/physical examination.
• Acute illness.
• Oral condition:
• Has history of oral surgery (including extractions) within 4 weeks, operative dental work within 7 days, or a presence of any clinically significant oral pathology (as determined by the investigator) including lesions, sores or inflammation which would interfere with assessments.
• Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with swilling or tasting the formulations.
• Has current or recurrent disease that could affect the mouth and interfere with the taste assessment.
• Has severe gingivitis, periodontitis or rampant caries.
• Has the presence of oral or peri-oral ulceration including herpetic lesions
• Has elective dentistry scheduled during the study duration.
• Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment.
• History of alcohol or other substance abuse within the year.
• A positive screen for alcohol or drugs of abuse.
• Confirmed systolic blood pressure \>139mmHg or \<89mmHg, and diastolic blood pressure \>89mmHg or\<49mmHg.
• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 19, 2014
• Study Start: February 28, 2014
• Primary Completion: March 19, 2014
• Study Completion: March 19, 2014
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

US (1)