- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905553
The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects
June 22, 2021 updated by: Shire
A Phase 1, Open-label, Randomized, 2-period, Crossover, Exploratory Study to Investigate the Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects
To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33014
- Clinical Pharmacology of Miami
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SSP-004184SS (fed)
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions
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Disodium salt
Other Names:
|
Experimental: SSP-004184SS (fasted)
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions
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Disodium salt
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions
Time Frame: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
|
AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity.
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.
|
Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions
Time Frame: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
|
AUClast is the area under the curve from the time of dosing to the last measurable 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.
|
Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
|
Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions
Time Frame: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
|
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.
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Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2013
Primary Completion (Actual)
September 24, 2013
Study Completion (Actual)
September 24, 2013
Study Registration Dates
First Submitted
July 18, 2013
First Submitted That Met QC Criteria
July 18, 2013
First Posted (Estimate)
July 23, 2013
Study Record Updates
Last Update Posted (Actual)
June 24, 2021
Last Update Submitted That Met QC Criteria
June 22, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- SPD602-113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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