IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics

Surgery Clinical Trial

Official title:

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System With Firefly® Fluorescent Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006237
• Other study ID #: ISI-001-01
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2016
• Last updated: March 1, 2018
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001

Description:

A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subject is between the ages of 18 and 65.

2. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.

3. Subject is willing and able to provide informed consent.

4. Subject is considered capable of complying with study procedures.

5. Subject has no medical history of liver or kidney disease.

6. Subject has no evidence of NYHA Class II-IV cardiac disease.

7. Subject has recent (< 3 months) clinical hematology (CBC) values within the acceptable values reference range.

8. Subject has recent (< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.

Exclusion Criteria:

1. Subject is pregnant or nursing.

2. Subject has a history of alcoholism.

3. Subject has a history of drug abuse.

4. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

5. Subject has known human immunodeficiency virus (HIV) infection.

6. Subject has been diagnosed with or treated for cancer in the last 2 years.

7. Subject has a total body weight < 32 kg.

8. Subject has after 5 minutes of supine rest a diastolic blood pressure =100 mmHg and/or a systolic blood pressure =160 mmHg.

9. Subject has after 5 minutes of supine rest a resting heart rate =35 or =115 bpm.

10. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.

Related Conditions & MeSH terms

• Hysterectomy
• Surgery

Intervention

Drug:
• IS-001
10mg, 20mg or 40 mg IV IS-001 drug administered during surgery

Device:
• da Vinci® Si/Xi Surgical System
robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging

Locations

Country	Name	City	State
United States	Las Palmas Medical Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)	Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events	14 days
Secondary	Evaluation of pharmacokinetic parameter of IS-001: Cmax	Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration	6 hours
Secondary	Evaluation of pharmacokinetic parameter of IS-001: Tmax	Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration	6 hours
Secondary	Evaluation of pharmacokinetic parameter of IS-001: t1/2	Pharmacokinetics for IS-001 as measured by terminal elimination half-life	6 hours
Secondary	Evaluation of pharmacokinetic parameter of IS-001: AUC	Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve	6 hours