Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905553
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE July 23, 2013
Results First Submitted Date  ICMJE December 16, 2014
Results First Posted Date  ICMJE December 24, 2014
Last Update Posted Date December 24, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions [ Time Frame: Over 96 Hours post-dose ]
    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.
  • 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: Over 96 hours post-dose ]
    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.
  • Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions [ Time Frame: Over 96 hours post-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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-004184 Under Fed Conditions [ Time Frame: Over 96 Hours post-dose ]
  • Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-004184 Under Fasted Conditions [ Time Frame: Over 96 hours post-dose ]
  • Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed Conditions [ Time Frame: Over 96 hours post-dose ]
  • Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fasted Conditions [ Time Frame: Over 96 hours post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects
Official Title  ICMJE 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
Brief Summary To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: SSP-004184SS
Disodium salt
Other Name: SPD602
Study Arms  ICMJE
  • Experimental: SSP-004184SS (fed)
    21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions
    Intervention: Drug: SSP-004184SS
  • Experimental: SSP-004184SS (fasted)
    21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions
    Intervention: Drug: SSP-004184SS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
8
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01905553
Other Study ID Numbers  ICMJE SPD602-113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Lasseter, MD Clinical Pharmacology of Miami
PRS Account Shire
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP