A Phase 1 interventional study of Icatibant (30 mg) in Hereditary Angioedema (HAE), sponsored by Shire. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by Shire · Phase 1, Interventional, and Treatment
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
Icatibant has been studied for the treatment of acute attacks of hereditary angioedema (HAE), an autosomal dominant disorder characterized by recurrent and self-limiting episodes of edema of the skin, larynx, and gastrointestinal tract. The most serious manifestation of an HAE attack is laryngeal edema, causing obstruction of the upper airways that may lead to death by asphyxiation if undiagnosed and/or untreated.
Icatibant has been approved in over 40 countries around the world including the United States (US) and Europe for the treatment of acute attacks of hereditary angioedema (HAE) in adults. This study is being conducted to evaluate the safety and tolerability of icatibant in a Japanese population and to evaluate whether race/ethnicity impacts the pharmacokinetics of icatibant after single subcutaneous injection.
This is an open-label, single-arm study that will enroll at least 12 Japanese subjects (in order to have 12 subjects complete the study), age 18-55 years inclusive. All subjects will receive a single subcutaneous injection of 30mg icatibant. The study will be conducted at 1 site in the US. The study will consist of a Screening Period, a Treatment Period, and a Follow-Up Period.
164 studies on the registry are indexed under Angioedema; 19 are open to participants now.
This study's enrollment of 12 is below the median of 44 across 111 interventional studies indexed under Angioedema.
Browse Angioedema studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
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Exclusion Criteria:
30mg dose of icatibant is administered as a single subcutaneous injection in the abdominal area
Drug: Icatibant (30 mg)
On Day 1, subjects will receive a single 30mg subcutaneous injection of icatibant in their abdominal area. Subjects will be discharged from the study on Day 3 after collection of study related assessments
Also known as: Firazyr
Peak Plasma Concentration (Cmax) of Icatibant and Metabolites
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
Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites
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
Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites
The time it takes for the blood plasma concentration of a substance to halve.
Time frame: Over 48 hours post-dose
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Icatibant and Metabolites
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
Total Body Clearance (CL/F) of Icatibant
The rate at which a drug is removed from the body.
Time frame: Over 48 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Icatibant and Metabolites
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
The Total Number of Treatment-Emergent Adverse Events
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
The Percentage of Subjects With Any Injection Site Reactions.
Time frame: Over 48 hours post-dose
Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results
Time frame: Over 48 hours post-dose
Change From Baseline in Diastolic Blood Pressure
Time frame: Over 48 hours post-dose
Change From Baseline in Systolic Blood Pressure
Time frame: Over 48 hours post-dose
Change From Baseline in Pulse Rate
Time frame: Over 48 hours post-dose
| Milestone | Icatibant (30 mg) |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| ng/mL | Icatibant (30 mg) |
|---|---|
| Icatibant | 1190 ± 261 |
| Metabolite 1 | 340 ± 67.7 |
| Metabolite 2 | 365 ± 74.8 |
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
| hr | Icatibant (30 mg) |
|---|---|
| Icatibant | 0.67 ± 0.20 |
| Metabolite 1 | 1.92 ± 0.289 |
| Metabolite 2 | 1.92 ± 0.289 |
The time it takes for the blood plasma concentration of a substance to halve.
| hr | Icatibant (30 mg) |
|---|---|
| Icatibant | 1.77 ± 0.356 |
| Metabolite 1 | 3.69 ± 0.579 |
| Metabolite 2 | 4.11 ± 1.01 |
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.
| ng*hr/mL | Icatibant (30 mg) |
|---|---|
| Icatibant | 2320 ± 403 |
| Metabolite 1 | 1750 ± 308 |
| Metabolite 2 | 1960 ± 346 |
The rate at which a drug is removed from the body.
| mL/hr | Icatibant (30 mg) |
|---|---|
| Total Body Clearance (CL/F) of Icatibant | 13200 ± 1890 |
Treatment-emergent adverse events (TEAEs) were those that started after the single dose of icatibant.
| Treatment Emergent Adverse Events | Icatibant (30 mg) |
|---|---|
| The Total Number of Treatment-Emergent Adverse Events | 2 |
| percentage of participants | Icatibant (30 mg) |
|---|---|
| Erythema | 100.00 |
| Warm sensation | 50.00 |
| Swelling | 91.67 |
| Cutaneous pain | 33.33 |
| Itching/Pruritus | 8.33 |
| Burning sensation | 8.33 |
| percentage of participants | Icatibant (30 mg) |
|---|---|
| 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 |
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.
| ng*hr/mL | Icatibant (30 mg) |
|---|---|
| Icatibant | 2320 ± 402 |
| Metabolite 1 | 1740 ± 307 |
| Metabolite 2 | 1950 ± 345 |
| mmHg | Icatibant (30 mg) |
|---|---|
| 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 |
| mmHg | Icatibant (30 mg) |
|---|---|
| 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 |
| beats per minute | Icatibant (30 mg) |
|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Icatibant (30 mg) | — | 0/12 (0%) | 2/12 (16.7%) |
| Event | Icatibant (30 mg) |
|---|---|
| CostochondritisMusculoskeletal and connective tissue disorders | 1/12 |
| Injection Site PainGeneral disorders | 1/12 |
The Safety Set consisted of all subjects who had taken the single dose of icatibant.
| Age, Categorical(Participants) | Icatibant (30 mg) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Age, Continuous(years) | Icatibant (30 mg) |
|---|---|
| Mean | 30.7 ± 8.08 |
| Sex: Female, Male(Participants) | Icatibant (30 mg) |
|---|---|
| Female | 6 |
| Male | 6 |
| Region of Enrollment(Participants) | Icatibant (30 mg) |
|---|---|
| United States | 12 |
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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