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

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

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

Study Overview

• Status: Completed
• Conditions: Surgery; Hysterectomy
• Intervention / Treatment: Drug: IS-001; Device: da Vinci® Si/Xi Surgical System

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79902
      • Las Palmas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV IS-001 drug; IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pharmacokinetic parameter of IS-001: Cmax	Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration	6 hours
Evaluation of pharmacokinetic parameter of IS-001: Tmax	Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration	6 hours
Evaluation of pharmacokinetic parameter of IS-001: t1/2	Pharmacokinetics for IS-001 as measured by terminal elimination half-life	6 hours
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

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Richard Farnam, MD, Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center

Publications and helpful links

General Publications

• Farnam RW, Arms RG, Klaassen AH, Sorger JM. Intraoperative ureter visualization using a near-infrared imaging agent. J Biomed Opt. 2019 Jun;24(6):1-8. doi: 10.1117/1.JBO.24.6.066004.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ISI-001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED