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

NCT03006237 | Completed Phase 1

• 1 other identifier: ISI-001-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hysterectomy; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of pharmacokinetic parameter of IS-001: Cmax

  6 hours

• Evaluation of pharmacokinetic parameter of IS-001: Tmax

  6 hours

• Evaluation of pharmacokinetic parameter of IS-001: t1/2

  6 hours

• Evaluation of pharmacokinetic parameter of IS-001: AUC

  6 hours

Study Arms (1)

IV IS-001 drug

EXPERIMENTAL

IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System

Drug: IS-001; Device: da Vinci® Si/Xi Surgical System

Interventions

IS-001 DRUG

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

IV IS-001 drug

da Vinci® Si/Xi Surgical System DEVICE

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

IV IS-001 drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between the ages of 18 and 65.
• Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.
• Subject is willing and able to provide informed consent.
• Subject is considered capable of complying with study procedures.
• Subject has no medical history of liver or kidney disease.
• Subject has no evidence of NYHA Class II-IV cardiac disease.
• Subject has recent (\< 3 months) clinical hematology (CBC) values within the acceptable values reference range.
• Subject has recent (\< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.

You may not qualify if:

• Subject is pregnant or nursing.
• Subject has a history of alcoholism.
• Subject has a history of drug abuse.
• Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Subject has known human immunodeficiency virus (HIV) infection.
• Subject has been diagnosed with or treated for cancer in the last 2 years.
• Subject has a total body weight \< 32 kg.
• Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.
• Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.
• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Las Palmas Medical Center

El Paso, Texas, 79902, United States

Location

Related Publications (1)

• 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.

  PMID: 31215195 DERIVED

MeSH Terms

Interventions

IS 001

Study Officials

• Richard Farnam, MD

  Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 30, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)