Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant (30 mg)
Intervention description: 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
Intervention MeSH terms: Icatibant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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

Summary:

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

Eligibility 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