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

Withdrawn before enrolling · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02065401

Run by

Shire

People needed

0

Starts

2014-02-28

Expected to finish

2014-03-19

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody.
• Current use of any other medication (including over-the-counter, herbal, or homeopathic preparations)
• Current use of iron supplements and/or multivitamins.
• Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products.
• Donation of blood or blood products (e.g., plasma or platelets) within 60 days.

Where it is running

• Clinical Pharmacology of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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