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

Phase 1

Completed

• Conditions: Hysterectomy; Surgery
• Interventions: Drug: IS-001; Device: da Vinci® Si/Xi Surgical System

• Registration Number: NCT03006237
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-30
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)	14 days	Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetic parameter of IS-001: Tmax	6 hours	Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration
Evaluation of pharmacokinetic parameter of IS-001: t1/2	6 hours	Pharmacokinetics for IS-001 as measured by terminal elimination half-life
Evaluation of pharmacokinetic parameter of IS-001: Cmax	6 hours	Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration
Evaluation of pharmacokinetic parameter of IS-001: AUC	6 hours	Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve

Trial Locations

Locations (1)

Las Palmas Medical Center; 🇺🇸 El Paso, Texas, United States