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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT02045264
First received: January 13, 2014
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.


Condition Intervention Phase
Hereditary Angioedema (HAE)
Drug: Icatibant (30 mg)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • PK parameters for icatibant include peak plasma concentration [ Time Frame: On Days 1-3 of the in-patient stay blood sample collection will occur prior to the administration of icatibant then at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16, 20, 24, and 48 hours post-icatibant administration. ] [ Designated as safety issue: No ]
    In healthy Japanese volunteers.

  • PK parameters for icatibant include time to reach peak plasma concentration [ Time Frame: On Days 1-3 of the in-patient stay blood sample collection will occur prior to the administration of icatibant then at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16, 20, 24, and 48 hours post-icatibant administration. ] [ Designated as safety issue: No ]
  • PK parameters for icatibant include time required for drug concentration to fall by half. [ Time Frame: On Days 1-3 of the in-patient stay blood sample collection will occur prior to the administration of icatibant then at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16, 20, 24, and 48 hours post-icatibant administration. ] [ Designated as safety issue: No ]
  • PK parameters for icatibant include area under plasma concentration versus time curve [ Time Frame: On Days 1-3 of the in-patient stay blood sample collection will occur prior to the administration of icatibant then at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16, 20, 24, and 48 hours post-icatibant administration. ] [ Designated as safety issue: No ]
  • PK parameters for icatibant include total drug clearance. [ Time Frame: On Days 1-3 of the in-patient stay blood sample collection will occur prior to the administration of icatibant then at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16, 20, 24, and 48 hours post-icatibant administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of treatment-emergent adverse events [ Time Frame: AEs will be collected from consent through follow-up visit, 5-7 days after the Icatibant administration (a maximum of 6 weeks) ] [ Designated as safety issue: Yes ]
  • The number and % of subjects with any injection site reactions. [ Time Frame: AEs will be collected from consent through follow-up visit, 5-7 days after the Icatibant administration (a maximum of 6 weeks) ] [ Designated as safety issue: Yes ]
  • Safety evaluation measured by change from baseline in vital signs, ECG findings, and Clinical Laboratory tests which will be summarized by treatment group and visit. [ Time Frame: Collected at Screening or at various time points on Day -1, 1, 2, or 3 of the in-clinic stay ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: February 2014
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icatibant (30 mg)
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
Other Name: Firazyr

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female volunteers, 18 to 55 years of age, inclusive; healthy status defined as absence of clinically significant findings in medical history or screening assessments
  2. Japanese; defined as born in Japan, lived outside of Japan for no more than 10 years, and having Japanese parents and Japanese maternal and paternal grandparents
  3. Body mass index of 18 to 28 kg/m2, inclusive

Exclusion Criteria:

  1. History of, or current, clinically significant disease and/or abnormalities
  2. Smoking habit in excess of 5 cigarettes per day or the equivalent within 30 days of Day 1 or inability to refrain from smoking during the study confinement period
  3. Subject has current abnormal thyroid function, as defined as abnormal screening thyroid stimulating hormone (TSH) and free thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 12 weeks is permitted
  4. History of drug allergy or other allergy that, in the opinion of the investigator, contraindicates participation
  5. Male subjects who consume more than 21 units of alcohol per week or 3 units per day. Female subjects who consume more than 14 units of alcohol per week or 2 units per day. (1 alcohol unit =1 beer or =1 wine (5oz/150mL) or =1 liquor (1.5oz/40mL) or =0.75oz alcohol)
  6. Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches. (1 caffeine unit is contained in the following items: one 6oz (180mL) cup of coffee, two 12oz (360mL) cans of cola, one 12oz cup of tea, three 1oz (85g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine)
  7. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) with the exception of female hormonal replacement therapy or hormonal contraceptives. Occasional use of over-the-counter doses of ibuprofen or acetaminophen for minor self-limited pain (eg, headaches) is also acceptable. Current use is defined as use within 7 days of the first dose of investigational product\
  8. Pregnant or lactating females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045264

Locations
United States, California
PAREXEL
Glendale, California, United States, 91206
Sponsors and Collaborators
Shire
Investigators
Study Director: Alan Kimura, MD, PhD Shire
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02045264     History of Changes
Other Study ID Numbers: SHP-FIR-101
Study First Received: January 13, 2014
Last Updated: August 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by Shire:
Firazyr
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Adrenergic beta-Antagonists
Icatibant
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Adrenergic Antagonists
Analgesics, Non-Narcotic
Neurotransmitter Agents
Peripheral Nervous System Agents
Sensory System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agents
Pharmacologic Actions
Therapeutic Uses
Analgesics

ClinicalTrials.gov processed this record on August 20, 2014