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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: SSP-004184SS
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SSP-004184SS Fed First SSP-004184SS Fasted First
Hide Arm/Group Description Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions. Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
Period Title: Period 1
Started 5 4
Completed 5 4
Not Completed 0 0
Period Title: Period 2
Started 5 4
Completed 4 4
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title SSP-004184SS Fed First SSP-004184SS Fasted First Total
Hide Arm/Group Description Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions. Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast. Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
The Safety Set consists of all subjects who have taken at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
4
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
42  (10.89) 35  (7.62) 38.9  (9.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
1
  20.0%
2
  50.0%
3
  33.3%
Male
4
  80.0%
2
  50.0%
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
UNITED STATES Number Analyzed 5 participants 4 participants 9 participants
5 4 9
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions
Hide Description 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.
Time Frame Over 96 Hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title SSP-004184SS (Fed) SSP-004184SS (Fasted)
Hide Arm/Group Description:
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
112,236.7  (28,804.8) 154,676.6  (28,185.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SSP-004184SS (Fed), SSP-004184SS (Fasted)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 0.718
Confidence Interval (2-Sided) 90%
0.670 to 0.770
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title SSP-004184SS (Fed) SSP-004184SS (Fasted)
Hide Arm/Group Description:
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
112,066.1  (28,822.9) 154,446  (28,066.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SSP-004184SS (Fed), SSP-004184SS (Fasted)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 0.718
Confidence Interval (2-Sided) 90%
0.670 to 0.769
Estimation Comments [Not Specified]
3.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions
Hide Description 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.
Time Frame Over 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SSP-004184SS (Fed) SSP-004184SS (Fasted)
Hide Arm/Group Description:
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
32,755.6  (11,797.4) 70,733.3  (9,782.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SSP-004184SS (Fed), SSP-004184SS (Fasted)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 0.449
Confidence Interval (2-Sided) 90%
0.380 to 0.530
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SSP-004184SS (Fed) SSP-004184SS (Fasted)
Hide Arm/Group Description 21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions. 21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
All-Cause Mortality
SSP-004184SS (Fed) SSP-004184SS (Fasted)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SSP-004184SS (Fed) SSP-004184SS (Fasted)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SSP-004184SS (Fed) SSP-004184SS (Fasted)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/9 (55.56%)      4/9 (44.44%)    
Musculoskeletal and connective tissue disorders     
Pain in extremity  1/9 (11.11%)  1 0/9 (0.00%)  0
Nervous system disorders     
Headache  2/9 (22.22%)  2 1/9 (11.11%)  1
Psychiatric disorders     
Agitation  0/9 (0.00%)  0 1/9 (11.11%)  2
Renal and urinary disorders     
Chromaturia  2/9 (22.22%)  2 2/9 (22.22%)  2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01905553    
Other Study ID Numbers: SPD602-113
First Submitted: July 18, 2013
First Posted: July 23, 2013
Results First Submitted: December 16, 2014
Results First Posted: December 24, 2014
Last Update Posted: December 24, 2014