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Trial record 2 of 23 for:    ICATIBANT

Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers

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ClinicalTrials.gov Identifier: NCT02045264
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hereditary Angioedema (HAE)
Intervention Drug: Icatibant (30 mg)
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
30.7  (8.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Icatibant and Metabolites
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 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Icatibant 1190  (261)
Metabolite 1 340  (67.7)
Metabolite 2 365  (74.8)
2.Primary Outcome
Title Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites
Hide Description Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: hr
Icatibant 0.67  (0.20)
Metabolite 1 1.92  (0.289)
Metabolite 2 1.92  (0.289)
3.Primary Outcome
Title Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites
Hide Description The time it takes for the blood plasma concentration of a substance to halve.
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: hr
Icatibant 1.77  (0.356)
Metabolite 1 3.69  (0.579)
Metabolite 2 4.11  (1.01)
4.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Icatibant and Metabolites
Hide Description AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero 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 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Icatibant 2320  (403)
Metabolite 1 1750  (308)
Metabolite 2 1960  (346)
5.Primary Outcome
Title Total Body Clearance (CL/F) of Icatibant
Hide Description The rate at which a drug is removed from the body.
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mL/hr
13200  (1890)
6.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Icatibant and Metabolites
Hide Description AUC0-t is the area under the plasma concentration versus time curve extrapolated from time 0 to to the last quantifiable 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 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Icatibant 2320  (402)
Metabolite 1 1740  (307)
Metabolite 2 1950  (345)
7.Secondary Outcome
Title The Total Number of Treatment-Emergent Adverse Events
Hide Description Treatment-emergent adverse events (TEAEs) were those that started after the single dose of icatibant.
Time Frame TEAEs were collected after the single dose of icatibant until follow up, 5-7 days after icatibant administration
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Treatment Emergent Adverse Events
2
8.Secondary Outcome
Title The Percentage of Subjects With Any Injection Site Reactions.
Hide Description [Not Specified]
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
Erythema 100.00
Warm sensation 50.00
Swelling 91.67
Cutaneous pain 33.33
Itching/Pruritus 8.33
Burning sensation 8.33
9.Secondary Outcome
Title Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results
Hide Description [Not Specified]
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of participants
Screening 91.67
Day 1, Pre-dose 50.00
Baseline 50.00
Day 1, 0.75 hours 33.33
Day 1, 8 hours 33.33
Day 2, 24 hours 66.67
Day 3, 48 hours 66.67
10.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, 0.5 h -2.0  (6.42)
Day 1, 1 h -3.8  (4.30)
Day 1, 2 h -5.2  (4.57)
Day 1, 4 h -5.2  (7.52)
Day 1, 6 h -4.8  (8.07)
Day 1, 8 h -4.5  (6.67)
Day 1, 12 h -3.4  (9.06)
Day 2, 24 h -1.8  (7.76)
Day 3, 48 h -5.3  (6.18)
11.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, 0.5 h -1.8  (12.07)
Day 1, 1 h -1.9  (13.03)
Day 1, 2 h -5.8  (14.21)
Day 1, 4 h -7.3  (17.06)
Day 1, 6 h -4.3  (16.20)
Day 1, 8 h -3.0  (11.52)
Day 1, 12 h -4.4  (14.11)
Day 2, 24 h -6.2  (11.98)
Day 3, 48 h -6.4  (12.72)
12.Secondary Outcome
Title Change From Baseline in Pulse Rate
Hide Description [Not Specified]
Time Frame Over 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description:
Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: beats per minute
Day 1, 0.5 h 1.4  (7.53)
Day 1, 1 h 0.1  (5.38)
Day 1, 2 h -3.0  (9.67)
Day 1, 4 h -6.3  (9.91)
Day 1, 6 h -0.1  (11.15)
Day 1, 8 h -3.6  (10.88)
Day 1, 12 h -3.2  (10.50)
Day 2, 24 h -6.8  (9.02)
Day 3, 48 h -4.0  (9.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Icatibant (30 mg)
Hide Arm/Group Description Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
All-Cause Mortality
Icatibant (30 mg)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Icatibant (30 mg)
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Icatibant (30 mg)
Affected / at Risk (%) # Events
Total   2/12 (16.67%)    
General disorders   
Injection Site Pain  1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Costochondritis  1/12 (8.33%)  1
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 Development LLC
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02045264     History of Changes
Other Study ID Numbers: SHP-FIR-101
First Submitted: January 13, 2014
First Posted: January 24, 2014
Results First Submitted: January 6, 2015
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015