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

NCT02045264 | Completed Phase 1 Results

• 1 other identifier: SHP-FIR-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hereditary Angioedema (HAE)

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  Over 48 hours post-dose

• Total Body Clearance (CL/F) of Icatibant

  The rate at which a drug is removed from the body.

  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.

  Over 48 hours post-dose

Secondary Outcomes (6)

• The Total Number of Treatment-Emergent Adverse Events

  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.

  Over 48 hours post-dose

• Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results

  Over 48 hours post-dose

• Change From Baseline in Diastolic Blood Pressure

  Over 48 hours post-dose

• Change From Baseline in Systolic Blood Pressure

  Over 48 hours post-dose

Study Arms (1)

Icatibant (30 mg)

EXPERIMENTAL

30mg dose of icatibant is administered as a single subcutaneous injection in the abdominal area

Drug: Icatibant (30 mg)

Interventions

Icatibant (30 mg) DRUG

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

Icatibant (30 mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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
• Body mass index of 18 to 28 kg/m2, inclusive

You may not qualify if:

• History of, or current, clinically significant disease and/or abnormalities
• 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
• 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
• History of drug allergy or other allergy that, in the opinion of the investigator, contraindicates participation
• 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)
• 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)
• 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\\
• Pregnant or lactating females

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

PAREXEL

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Angioedemas, Hereditary; Angioedema; Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Genetic Diseases, Inborn

Interventions

icatibant

Condition Hierarchy (Ancestors)

Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Immunologic Deficiency Syndromes

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 24, 2014
• Study Start: February 21, 2014
• Primary Completion: February 27, 2014
• Study Completion: February 27, 2014
• Last Updated: June 3, 2021
• Results First Posted: January 14, 2015

Record last verified: 2021-05

Locations

US (1)