The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects

NCT ID: NCT01905553

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-27
• Study Completion Date: 2013-09-24

Brief Summary

To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SSP-004184SS (fed)

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

Group Type: EXPERIMENTAL

SSP-004184SS

Intervention Type: DRUG

Disodium salt

SSP-004184SS (fasted)

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

Group Type: EXPERIMENTAL

SSP-004184SS

Intervention Type: DRUG

Disodium salt

Interventions

SSP-004184SS

Disodium salt

Intervention Type: DRUG

Other Intervention Names

SPD602

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit.
• Subject is considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
• Serum ferritin >20ng/mL, hemoglobin >125g/l, and erythrocyte indices within normal range of the clinical laboratory at the Screening Visit and on Day -1: packed cell volume, mean corpuscular volume, and mean corpuscular hemoglobin concentration, or deemed not clinically significant by the investigator.
• Subject is willing 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 [amenorrhea for at least 12 consecutive months] or surgically sterile [hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or bilateral salpingectomy]) and at least 6 weeks post-sterilization
• Non-pregnant, non-lactating female
• At least 90 days post-partum or nulliparous (females only).
• An understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on Harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
• Body mass index between 18.5-30.0kg/m² inclusive. This inclusion criterion will be assessed only at the Screening Visit.
• Ability to swallow the investigational product (multiple capsules at 1 time or consecutively 1 capsule at a time).

Exclusion Criteria

• A clinically significant history or disorder detected during the medical interview/physical examination such as any cardiovascular, bronchopulmonary, gastrointestinal (eg, inflammatory bowel disease, chronic diarrhea), hepatic, biliary (including gall bladder removal), renal, hematological, endocrine, autoimmune, neurological, or psychiatric disease (including depression) or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs; or of constituting a risk factor when taking the investigational product in the judgment of the investigator.
• Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
• Twelve-lead ECG demonstrating QTc >450msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
• Subject reports any food allergies, celiac disease, or requirements for specific diet (eg, vegan, vegetarian, low fat).
• 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.
• History of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months of the Screening Visit.
• History of alcohol or other substance abuse within the last year.
• Routine consumption of more than 3 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
• A positive screen for alcohol or drugs of abuse at the Screening Visit.
• 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 screen, or hepatitis C virus antibody screen.
• Current use of any other medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the study evaluations according to the investigator.
• 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.
• Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to Day 1 of Treatment Period 1.
• Use of another investigational product within 30 days prior to Day 1 of Treatment Period 1 or active enrollment in another drug or vaccine clinical study.
• Substantial changes in eating habits within 30 days prior to Day 1 of Treatment Period 1, as assessed by the investigator.
• Prior screen failure, randomization, participation, or enrollment in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Clinical Pharmacology of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

SPD602-113

Identifier Type: -

Identifier Source: org_study_id