A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers

NCT03340870 | Completed Phase 1

• 1 other identifier: GE-045-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine the Pharmacokinetics (PK) data of perfluorobutane (PFB) in blood and exhaled air following intravenous (I.V.) bolus injection of Sonazoid™ in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (16)

• Area Under the Concentration Versus Time Curve from Time Zero to the Last Time- Point (AUC 0-last), AUC from Time Zero to Infinity (AUC0-infinity∞) After Single Dose in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Area Under the Concentration Versus Time Curve from Time Zero to the Last Time- Point (AUC 0-last), AUC from Time Zero to Infinity (AUC0-Infinity∞) After Single Dose in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Elimination Rate Constant (kel) in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Elimination Rate Constant (kel) in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Elimination Half-life (t½) in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Elimination Half-life (t½) in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Clearance (Cl) in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Clearance (Cl) in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Maximum Observed Concentration (Cmax) in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Maximum Observed Concentration (Cmax) in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Time at which Cmax is reached (tmax) in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Time at which Cmax is reached (tmax) in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

• Volume of Distribution (Vd) in Blood

  Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose

• Volume of Distribution (Vd) in Exhaled Air

  Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

Secondary Outcomes (5)

• Percentage of Participants With Treatment-Related Adverse Events (AEs)

  Up to 72 hours after first administration of investigational medicinal product (IMP)

• Percentage of Participants With Abnormal Laboratory Values

  Up to 4 hours post dose

• Percentage of Participants With Abnormal Vital Signs

  Up to 4 hours post dose

• Percentage of Participants With Injection Site Reactions

  Up to 4 hours post dose

• Percentage of Participants With Abnormal Physical Examinations

  Up to 4 hours post dose

Study Arms (2)

Sonazoid™ 0.12 microliter (µl)

EXPERIMENTAL

Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 µl microbubbles (MB)/kilogram (kg) body weight.

Drug: Sonazoid™

Sonazoid™ 0.60 µl

EXPERIMENTAL

Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight.

Drug: Sonazoid™

Interventions

Sonazoid™ DRUG

Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.

Also known as: perfluorobutane

Sonazoid™ 0.12 microliter (µl); Sonazoid™ 0.60 µl

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is between 18 and 45 years of age
• Participant is male, or a female who was either surgically sterile (has a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of Sonazoid™ administration (with the result known before IMP administration), were negative
• Participant is able and willing to comply with study procedures and provide signed and dated informed consent
• Participant has a body mass index of 19 to 26
• Participant has agreed not to smoke from 2 hours before to 5 hours after Sonazoid™ administration
• Participant has agreed to avoid strenuous physical activity from 1 week before Sonazoid™ administration until the end of the study follow-up
• Participant has no history of alcohol or substance abuse, and has agreed to no intake of alcohol or drugs for 48 hours before Sonazoid™ administration and until the end of the study follow-up
• Participant has a normal health status, as judged by medical history and physical examination at screening
• Normal 12-lead electrocardiogram (ECG) at screening. Minor abnormalities considered by the investigator to be of no clinical importance are permitted
• Normal blood and urine clinical chemistry variables at screening. Isolated or minimally out-of-range values considered by the investigator to be of no clinical importance are permitted
• No regular use of concomitant medication, except for routine use of supplemental oestrogen

You may not qualify if:

• Participant was previously included in this study
• Participation in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
• Participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral and laryngeal swelling, hypotension or shock)
• Donation of \>500 milliliter (mL) blood in the 12 weeks before Sonazoid™ administration
• Participant with congenital heart defects, including right-to-left, bi-directional, or transient right-to-left cardiac shunts
• Participant has positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu

Chaoyang, Beijing Municipality, China

Location

MeSH Terms

Interventions

Sonazoid; perfluorobutane

Study Officials

• Francois Tranquart, MD, PhD

  GE Healthcare

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 14, 2017
• Study Start: October 20, 2014
• Primary Completion: November 20, 2014
• Study Completion: November 20, 2014
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

CN (1)